Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
8,082
Countries
16
Sites
243
Breast Neoplasms
To evaluate the efficacy of imlunestrant (Arm A) vs SOC adjuvant ET (Arm B), in patients who have received 2 to 5 years of standard ET for ER+, HER2- EBC with an increased risk of recurrence
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Apr 2023 → ongoing
- Decision date (initial)
- 2023-03-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501007-28-00
- WHO UTN
- U1111-1282-8627
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety
To evaluate the efficacy of imlunestrant (Arm A) vs SOC adjuvant ET (Arm B), in patients who have received 2 to 5 years of standard ET for ER+, HER2- EBC with an increased risk of recurrence
Secondary objectives 5
- To evaluate the efficacy of Arm A compared to Arm B in terms of DRFS, OS, and IDFS, including second non-breast primary invasive cancers
- To assess the safety and tolerability of each treatment arm
- To assess the PK of imlunestrant
- To describe health-related quality of life of each treatment arm
- To describe patient-reported overall AE burden of each treatment arm
Conditions and MedDRA coding
Breast Neoplasms
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Parallel Assignment N/A
|
Randomised Controlled | None | Experimental: Imlunestrant administered orally. Active Comparator: Investigator's Choice of Endocrine Therapy Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label. |
Regulatory references
- Scientific advice from competent authorities
- European Medical Contract Manufacturing B.V.
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Have early-stage ER+ HER2- breast cancer
- Have already had surgery to treat the breast cancer
- Have higher-than-average risk for the breast cancer to come back
- Have been taking a drug that blocks the production/action of estrogen for the last two to five years
- Be able to walk and able to carry out light work
- Have adequate body organ function
Exclusion criteria 2
- Have breast cancer that is advanced or has spread to another part(s) of the body
- Have a serious medical condition (other than this cancer)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Invasive Disease-Free Survival (IDFS)
Secondary endpoints 7
- Distant Recurrence-Free Survival (DRFS)
- Overall Survival (OS)
- Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
- Change from Baseline in the EORTC QLQ-C30 Role Functioning
- Change from Baseline in the EORTC QLQ-C30 Global QOL
- Proportion of Time on Study Treatment with High Overall Adverse Event Burden
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8876765 · Product
- Active substance
- LY3484356
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 730800 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 4
SCP202373 · ATC
- Active substance
- Tamoxifen
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 36540 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA01 — TAMOXIFEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP140009 · ATC
- Active substance
- Anastrozole
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1827 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139728 · ATC
- Active substance
- Exemestane
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 45675 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP236273 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 4568 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
-
L02AE · Product
- Pharmaceutical form
- PHF00243MIG
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 2160 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Other |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other, Data management |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifissia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
16 EU/EEA countries · 243 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 39 | 6 |
| Belgium | Ongoing, recruitment ended | 172 | 18 |
| Czechia | Ongoing, recruitment ended | 60 | 9 |
| Finland | Not authorised | 80 | 5 |
| France | Ongoing, recruitment ended | 328 | 35 |
| Germany | Ongoing, recruitment ended | 328 | 38 |
| Greece | Ongoing, recruitment ended | 175 | 15 |
| Hungary | Ongoing, recruitment ended | 61 | 5 |
| Ireland | Ongoing, recruitment ended | 156 | 9 |
| Italy | Ongoing, recruitment ended | 242 | 19 |
| Netherlands | Ongoing, recruitment ended | 74 | 11 |
| Poland | Ongoing, recruitment ended | 56 | 9 |
| Portugal | Ongoing, recruitment ended | 46 | 5 |
| Romania | Ongoing, recruitment ended | 106 | 11 |
| Slovakia | Ongoing, recruitment ended | 21 | 2 |
| Spain | Ongoing, recruitment ended | 548 | 46 |
| Rest of world
Korea, Republic of, Argentina, Singapore, Canada, Australia, India, Hong Kong, Japan, United Kingdom, China, United States, Taiwan, Turkey, Brazil, Israel, Mexico
|
— | 5,590 | — |
Investigational sites
Medical University Of Graz
Department of Obstetrics and Gynaecology, Division of Gynaecology, Neue Stiftingtalstrasse 6, 8010, Graz
Private Practice - Dr. Hubalek
Private Practice - Dr. Hubalek, Andreas-Hofer Straße 8, 6130, Schwaz
Medical University Of Vienna
Department of Obstetrics and Gynecology, Division of General Gynecology and Gynecologic Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Vienna
Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinik Hietzing
Division of Gynecology and Obstetrics, Wolkersbergenstraße 1, Hietzing, Vienna
SCRI – CCCIT Ges.m.b.H.
3rd Medical Department of University Hospital Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg
Algemeen Ziekenhuis Oostende
Oncology, Gouwelozestraat 100, 8400, Ostend
CHU Saint Pierre
Oncology, Hoogstraat 322, 1000, Brussels
Pole Hospitalier Jolimont
Medical Oncology, Rue Ferrer 159, 7100, La Louviere
Grand Hopital De Charleroi
Medical Oncology, Grand'rue 3, 6000, Charleroi
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Brussels
Verenigde Ziekenhuizen van Waas en Durme
Medical Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Algemeen Ziekenhuis Groeninge
Medical Oncology, President Kennedylaan 4, 8500, Kortrijk
UZ Leuven
Gynecologic Oncology, Herestraat 49, 3000, Leuven
CHU De Liège
Medical Oncology, Avenue De L'hopital 1, 4000, Liege
ISPPC CHU Charleroi
oncologie, Boulevard Zoe Drion 1, 6000, Charleroi
Chu Brugmann
Oncology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Clinique Saint-Pierre
Oncology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Jan Yperman Ziekenhuis
Medical Oncology, Briekestraat 12, 8900, Ieper
CHU UCL Namur
Oncology, Place Louise Godin 15, 5000, Namur
Chirec
Medical Oncology, Boulevard Du Triomphe 201, 1160, Brussels
CHR Verviers
Oncology, Rue Du Parc 29, 4800, Verviers
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice V Motole
Onkologicka klinika 2. LF UK a FN Motol, V Uvalu 84, 150 06, Prague 5
Multiscan s.r.o.
Oncology, Okruhova 1135/44, 155 00, Prague 13
NH Hospital a.s.
Onkologicky Stacionar, Okruhova 1135 44, 155 00, Prague 5
Fakultni Nemocnice V Motole
Onkologicka klinika 2. LF UK a FN Motol, V Uvalu 84, 150 06, Prague 5
Fakultni Nemocnice Bulovka
Ustav Radiacni Onkologie, Budinova 67/2, Liben, Prague
University Hospital Ostrava
Klinika onkologicka, 17 Listopadu 1790 5, 708 00, Ostrava Poruba
Masaryk Memorial Cancer Institute
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Thomayerova nemocnice
Onkologicka klinika 1. LF UK, Videnska 800, Krc, Prague 4
Tampere University Hospital
Oncology, Teiskontie 35, 33520, Tampere
Docrates Oy
Ongology, Saukonpaadenranta 2, 00180, Helsinki
Vaasa Central Hospital
Ongology, Hietalahdenkatu 2-4, 65130, Vaasa
Pohjois-Pohjanmaan Sairaanhoitopiirin kuntayhtyma
Oncology, Kajaanintie 50, 90220, Oulu
Central Finland Hospital District Central Finland Hospital Nova
Oncology, Hoitajantie 3, 40620, Jyvaskyla
Besancon University Hospital Center
Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, Boulevard Tanguy Prigent, 29200, Brest
Polyclinique De Limoges
N/A, 18 Rue Du General Catroux, 87039, Limoges Cedex I
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
N/A, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Oncology, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Centre Hospitalier Universitaire Grenoble Alpes
Oncology, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Clinique Victor Hugo
Oncology, 18 Rue Victor Hugo, Cs 81514, Le Mans Cedex 2
Centre De Cancerologie Du Grand Montpellier
Oncology, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Sud Francilien
Oncology, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Departmental Hospital Vendee
Onco-Hematology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Institut De Cancerologie De Lorraine
Oncology, 6 Avenue De Bourgogne, 54500, Vandouvre-Les-Nancy
Institut De Cancerologie De L Ouest
Oncology, Boulevard Jacques Monod, 44805, Saint Herblain
Hopital Tenon
Oncology, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Hospitalier Universitaire De Poitiers
Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Groupe Hospitalier Diaconesses Croix Saint Simon
URCEC, 125 Rue D Avron, 75020, Paris
Polyclinique De Gentilly
Oncology, Rue Marie Marvingt, 54000, Nancy
Centre Catalan D'oncologie
Oncology, 80 Rue Pascal Marie Agasse, 66000, Perpignan
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Oncology, Avenue Pierre De Coubertin, Bp 417, Mont-De-Marsan Cedex
Centre Hospitalier Prive Saint-Gregoire
Oncology, 6 Boulevard De La Boutiere, Cs 56816, Saint-Gregoire
Assistance Publique Hopitaux De Paris
Oncology, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Polyclinique De Blois
Oncology, 1 Rue Robert Debre, 41260, La Chaussee-Saint-Victor
Pole Sante Republique
Oncology, 105 Avenue De La Republique, 63050, Clermont-Ferrand Cedex 2
Assistance Publique Hopitaux De Paris
Oncology, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier De Pau
Oncology, 4 Boulevard Hauterive, 64000, Pau
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Sainte Catherine
Oncology, 250 Chemin De Baigne Pieds, 84000, Avignon
Hopital Saint Louis
Oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Nouvelle Clinique des Dentellieres
Oncology, 8 Avenue Vauban, 59300, Valenciennes
Hopital Prive Jean Mermoz
Oncology, 55 Avenue Jean Mermoz, 69008, Lyon
Centre Hospitalier De La Cote Basque
Oncology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospital Region Metz Thionville
Oncology, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
Institut Curie
Oncology, 26 Rue D Ulm, 75005, Paris
Institut Godinot
Clinical Research Unit, 1 Rue Du General Koenig, 51100, Reims
Klinikverbund Allgau gGmbH
Klinikverbund Allgaeu, Robert Weixler Strasse 50, West, Kempten (Allgau)
Haematologie-Onkologie im Zentrum MVZ GmbH
Oncology, Halderstrasse 29, Innenstadt, Augsburg
ConMed GmbH
Oncology, Nikolausberger Weg 34, 37073, Göttingen
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Innere Medizin I, Feldstrasse 16, Innenstadt, Trier
Onkologische Schwerpunktpraxis Kurfuerstendamm
Onkologische Schwerpunktpraxis Kurfuerstendamm, Kurfuerstendamm 65, Charlottenburg, Berlin
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Klinik für Gynäkologie und Geburtshilfe, Ludwig-Erhard-Strasse 90, Dotzheim, Wiesbaden
St. Anna Hospital
Brustzentum, Hospitalstrasse 19, Wanne, Herne
Oncologianova GmbH Gesellschaft fuer Innovationen in der Onkologie
Oncology, Am Stadion 9, Hillerheide, Recklinghausen
Praxisklinik Krebsheilkunde Fuer Frauen
Praxisklinik Krebsheilkunde fur Frauen, Moellendorffstrasse 52, Lichtenberg, Berlin
Staedtisches Klinikum Dessau
Oncology, Auenweg 38, Alten, Dessau-Roßlau
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Oncology, Wilhelm-Epstein-Straße 4, Bockenheim, Frankfurt Am Main
Universitatsklinikum Erlangen AöR
Oncology, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Universitaetsklinikum Tuebingen
Oncology, Calwerstrasse 7, Innenstadt, Tuebingen
Marienhospital Bottrop gGmbH
Oncology, Josef-Albers-Straße 70, Süd-West-Innenstadt, Bottrop
Onkologisch-hämatologisches Forschungsinstitut
Oncology, Polcherstr. 5-13, 56727, Mayen
University Hospital Cologne AöR
Universitaetsklinikum Koeln, Kerpener Strasse 62, Lindenthal, Cologne
Klinikum Ernst Von Bergmann gGmbH
Oncology, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
University Hospital Augsburg
Oncology, Stenglinstrasse 2, Kriegshaber, Augsburg
Medical Center - University Of Freiburg
Klinik für Frauenheilkunde, Universitaetsklinikum Freiburg", Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Onkologische Schwerpunktpraxis Heidelberg
Oncology, Kurfürsten-Anlage 36, 1. Stock, Heidelberg
Srh Zentralklinikum Suhl GmbH
Oncology, Albert-Schweitzer-Strasse 2, 98527, Suhl
St Johannes Hospital gGmbH
Oncology, Johannesstrasse 9-17, Mitte, Dortmund
Helios Klinikum Berlin-Buch GmbH
Oncology, Schwanebecker Chaussee 50, Buch, Berlin
Srh Wald-Klinikum Gera GmbH
Oncology, Strasse Des Friedens 122, Debschwitz, Gera
Klinikum Der Universitat Munchen AöR
Oncology, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
MVZ GynKrefeld GmbH
Oncology, Lutherplatz 40, Diessem/Lehmheide, Krefeld
Robert-Bosch-Krankenhaus GmbH
Oncology, Auerbachstraße 110, Bad Cannstatt, Stuttgart
Helios Kliniken Schwerin GmbH
HELIOS Kliniken Schwerin, Wismarsche Strasse 393-397, 19049, Schwerin
GynOnco Düsseldorf
N/A, Luise-Rainer-Strasse 6-10, 40235, Düsseldorf
Universitat Heidelberg
Oncology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Onkologiezentrum Donauwörth
Oncology, Neudegger Allee 10, 86609, Donauwörth
Diakonissen-Stiftungs-Krankenhaus Speyer gGmbH
Diakonissen-Stiftungs-Krankenhaus Speyer gGmbH, Paul-Egell-Strasse 33, Sued, Spires
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Senologie/Brustzentrum, Henricistraße 92, Huttrop, Essen
University Medical Centre Schleswig-Holstein
Oncology, Arnold-Heller-Straße 3, Brunswik, Kiel
Universitatsklinikum Ulm AöR
Oncology, Prittwitzstrasse 43, Mitte, Ulm
Universitaetsklinikum Magdeburg AöR
Universitätsklinik für Frauenheilkunde, Geburtshilfe und Re, Gerhart-Hauptmann-Strasse 35, Stadtfeld Ost, Magdeburg
MM-Medizinische Management GmbH
Praxis und Tagesklinik Prof. Dr. Helmut Oettle und Prof. Dr. Dr. Frank Mayer, Friedrichstraße 53, 88045, Friedrichshafen
Saarland University Hospital
Universitätsklinik des Saarlandes Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin, Gebaeude 40, Kirrberger Strasse 100, Homburg
Olympion Therapeftirio General Clinic Of Patras S.A.
Division of Oncology, Volou & Meilichou, Kato Sychaina, Patra
Alexandra Hospital
Oncology Department, University Clinic of Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
General University Hospital Of Patras
Internal Medicine Clinic-Oncology Department, Rio, 265 04, Patras
University General Hospital Of Ioannina
Oncology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Heraklion
Internal Medicine-Oncology Department, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Larissa
Oncology Department, P. O. Box 1425, 411 10, Larissa
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Department of Medical Oncology, Noufaron & Timiou Stavrou, 14564, N. Kifissia
Bioclinic S.A.
Oncology Unit, Mitropoleos 86, 546 22, Thessaloniki
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
2nd Oncology Clinic, Kifissias Leoforos 37-39, 151 23, Filothei
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
4th Oncology Clinic, Kifissias Leoforos 37-39, 151 23, Filothei
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
St. Luke's Hospital S.A.
Department of Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
University General Hospital Attikon
2nd Propaedeutic Pathology Clinic, Oncology Unit, Rimini Street 1, 124 62, Athens
Athens Medical Center S.A.
3rd department of Oncology, Pylea, Asklipiou 10, Thessaloniki
St Savas Hospital
2nd Department of Internal Medicine - Oncology, Alexandras Avenue 171, 115 22, Athens
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Onkoradiológiai Osztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
University Of Debrecen
Onkológiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Budapesti Uzsoki Utcai Korhaz
Onkoradiológiai Osztály, Uzsoki Utca 29-41, 1145, Budapest XIV
Orszagos Onkologiai Intezet
Kemoterápia B osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
University Hospital Waterford
Oncology, Dunmore Road, X91 ER8E, Waterford
Bon Secours Hospital Cork
Oncology, College Road, T12 DV56, Cork
Beacon Hospital
Oncology, Beacon Court, D18 AK68, Dublin 18
St Vincent's University Hospital
Oncology, Nutley Lane, Elm Park, Dublin 4
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
University Hospital Galway
Oncology, Newcastle Road, H91 YR71, Galway
Beaumont Hospital
Oncology, Beaumont Road, Beaumont, Dublin 9
Sligo University Hospital
Oncology, The Mall, F91 H684, Sligo
St James's Hospital
HOPE Directorate, James's Street, D08 NHY1, Dublin 8
European Institute Of Oncology S.r.l.
Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Medicina Clinica e Chirurgia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera S Maria Di Terni
S.C. Oncologia Medica e Traslazionale, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Ospedaliero Universitaria Di Modena
DH Oncologia, Largo Del Pozzo 71, 41124, Modena
Azienda Socio Sanitaria Territoriale Di Monza
Oncologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Ospedale S G Moscati
U.O.C. Oncologia Medica, Via Per Martina Franca, 74010, Statte
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Sperimentazioni di fase IV, Via Elio Chianesi N 53, 00144, Rome
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Day Hospital Oncologico Multidisciplinare, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Veneto Institute Of Oncology
Oncologia 2, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Parma
UO Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma
Humanitas Research Hospital
U.O di Oncologia Medica ed ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
Clinica Oncologica, Via Conca 71, 60126, Ancona
Humanitas Istituto Clinico Catanese S.p.A.
Humanitas Istituto Clinico Catanese, Contrada Cubba Sp54 11, 95045, Misterbianco
Azienda Sanitaria Locale Br
Medical Oncology Division, Via Napoli 8, 72100, Brindisi
Azienda Ospedaliera Papa Giovanni XXIII
Oncologia, Piazza Oms 1, 24127, Bergamo
IRCCS Istituto Nazionale Tumori - Fondazione Pascale
Senologia Medica, Via Mariano Semmola 53, 80131, Naples
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
SSD Oncologia medica Addarii, Viale Giambattista Ercolani 4/2, Pavillon 25/first floor, Bologna
Careggi University Hospital
SOD Radioterapia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Ospedale Policlinico San Martino
Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Spaarne Gasthuis
Oncology, Spaarnepoort 1, 2134 TM, Hoofddorp
Deventer Ziekenhuis
Research oncology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Internal medicine - oncology, Tegelseweg 210, 5912 BL, Venlo
Albert Schweitzer Ziekenhuis
Internal medicine - oncology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Stichting Zaans Medisch Centrum
Oncology, Koningin Julianaplein 58, 1502 DV, Zaandam
Reinier De Graaf
Research Unit Oncology, Reinier De Graafweg 5, 2625 AD, Delft
Maastricht University
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Wilhelmina Ziekenhuis Assen
Medical Oncology, Europaweg-Zuid 1, 9401 RK, Assen
Amphia Hospital
Oncology, Molengracht 21, 4818 CK, Breda
Haga Hospital
Oncology, Leyweg 275, 2545 CH, Hague
Stichting Ziekenhuisgroep Twente
Oncology, Zilvermeeuw 1, 7609 PP, Almelo
Mazowiecki Szpital Wojewódzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
N/A, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Szpitale Pomorskie Sp. z o.o.
N/A, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Stefana Batorego 18/22, 87-100, Torun
Lux Med Onkologia Sp. z o.o.
N/A, Ul. Szamocka 6, 01-748, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu
N/A, Ul. Katowicka 66a, 45-061, Opole
Formed 2 Sp. z o.o.
N/A, Ul. Wysokie Brzegi 4, 32-600, Oswiecim
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
N/A, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Salve Medica Sp. z o.o. S.K.
N/A, Ul. Sw. Anny 62, 95-060, Brzeziny
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
N/A, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Garcia De Orta E.P.E.
Oncology, Avenida Torrado Da Silva, 2801-951, Almada
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Oncology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Da Luz S.A.
Centro de Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Champalimaud Clinical Centre
Breast unit, Avenida Brasilia S/n, 1400-038, Lisbon
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Serviço de Oncologia Médica, Avenida Professor Egas Moniz, 1649-035, Lisbon
Oncocenter Oncologie Clinica S.R.L.
Oncology, Strada Garii 1a, 300166, Timisoara
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Spitalul Clinic Coltea
Oncology, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Ovidius Clinical Hospital S.R.L.
Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Gral Medical S.R.L.
Oncology, Strada Popovici Traian 79-91, 031422, Bucharest
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Oncology, Strada Crisului Nr. 1, 500283, Brasov
Onco-Medint S.R.L.
Oncology, Povernei Street No. 40-42, Camera 11 Etaj 2, Bucharest
Memorial Healthcare International S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Institute Of Oncology Prof Dr Ion Chiricuta Cluj Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Radiology Therapeutic Center S.R.L.
Oncology, Strada Drumul Odai Nr 42, 075100, Otopeni
Lotus Med S.R.L.
Oncology, Strada Dornei 79-81, 012292, Bucharest
Narodny Onkologicky Ustav
Národný Onkologický Ústav, Klenova 1, Nove Mesto, Bratislava
Onkologicky Ustav Sv Alzbety s.r.o.
Onkologický ústav, Heydukova 10, Stare Mesto, Bratislava
Hospital Ruber Internacional
Oncology, Calle La Maso 38, 28035, Madrid
Hospital Universitario De Jaen
Servicio de Oncología Médica, Avenida Del Ejercito Espanol 10, 23007, Jaen
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari General De Catalunya
Instituto Oncológico Dr Rosell, Calle Pedro I Pons 1, 08195, Barcelona
Hospital Vithas Parque San Antonio
Ensayos Clínicos Oncología, Avenida Del Pintor Joaquin Sorolla 2, 29016, Malaga
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Hospital Universitario Nuestra Senora de Candelaria
Medical Oncology, Carretera De Rosario 145, 38010, Santa Cruz De Tenerife
Salut Sant Joan De Reus
Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Area De Salud De Valladolid Este
Unidad de Oncología Médica, Avenida De Ramon Y Cajal 7, 47003, Valladolid
Hospital Universitario De Getafe
Oncologia, Ctra. De Toledo Km. 12, 28905, Getafe
Hospital Mateu Orfila
Oncología Médica, Ronda De Malburguer 1, 07703, Mahon
Hospital Universitario Torrecardenas
Oncology, Calle Paraje Torrecardenas S/n, 04009, Almería
Hospital Universitario Virgen De La Macarena
Unidad de Investigación Oncológica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Del Mar
Oncologia, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario La Paz
Oncología Médica, Paseo Castellana 261, 28046, Madrid
Hospital Universitario De Toledo Ute
Oncology, Avenida Río Guadiana Sn, 45007, Toledo
Hospital Universitario Clinico San Cecilio
ONCOLOGÍA, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Complejo Hospitalario Universitario De Caceres
Oncologia, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital San Pedro
Medical Oncology, Calle Piqueras 98, 26006, Logrono
Hospital Universitario De La Princesa
Oncology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Quironsalud Valencia
Oncology Department, Avenida Blasco Ibanez 14, 46010, Valencia
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De Navarra
Medical Oncology, Irunlarrea Kalea 3, 31008, Pamplona
University Hospital Of Canary Islands
Medical Oncology, Carretera Cuesta Taco S/N, 38320, San Cristobal De La Laguna
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario De Burgos
Oncology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital General De Segovia
Oncology, Calle De Luis Erik Claveria S/n, 47002, Segovia
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Dexeus Grupo Quironsalud
Instituto Oncológico Dr Rosell, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitari Vall D Hebron
Departamento de Oncologia- VHIO, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
University Clinical Hospital Virgen De La Arrixaca
ONCOLOGÍA MÉDICA, Carretera De Cartagena S/n, El Palmar, Murcia
Hospital General Universitario De Alicante
Oncology, ª Centro De Diagnosticos, Avinguda Del Pintor Baeza 12, Alicante
Hospital Universitario Infanta Leonor
Oncology, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Infanta Cristina
Oncología Médica, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Lucus Augusti
Oncology, Calle Ulises Romero 1, 27003, Lugo
Complexo Hospitalario Universitario A Coruna
MEDICAL ONCOLOGY, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Quironsalud Barcelona
IOB Institute of Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
MEDICAL ONCOLOGY, Av. Alcalde Rovira Roure 80, 25198, Lleida
Hospital Universitario Basurto
ONCOLOGIA MEDICA, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital De La Santa Creu I Sant Pau
Oncología Médica, Calle De San Antonio Maria Claret 167, 08025, Barcelona
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 |
|---|---|---|---|---|---|
| Austria | 2023-05-08 | 2023-05-22 | 2025-11-12 | ||
| Belgium | 2023-05-03 | 2023-06-14 | 2025-11-12 | ||
| Czechia | 2023-05-15 | 2023-05-31 | 2025-11-12 | ||
| France | 2023-04-19 | 2023-05-16 | 2025-11-12 | ||
| Germany | 2023-04-28 | 2023-05-26 | 2025-11-12 | ||
| Greece | 2023-05-26 | 2023-05-29 | 2025-11-12 | ||
| Hungary | 2023-05-26 | 2023-09-14 | 2025-11-12 | ||
| Ireland | 2023-10-30 | 2024-01-29 | 2025-11-12 | ||
| Italy | 2023-05-26 | 2023-07-10 | 2025-11-12 | ||
| Netherlands | 2023-05-03 | 2023-06-15 | 2025-11-12 | ||
| Poland | 2023-05-05 | 2023-07-06 | 2025-11-12 | ||
| Portugal | 2024-03-21 | 2024-07-11 | 2025-11-12 | ||
| Romania | 2023-04-18 | 2023-05-08 | 2025-11-12 | ||
| Slovakia | 2023-07-19 | 2023-07-19 | 2025-11-12 | ||
| Spain | 2023-04-24 | 2023-04-27 | 2025-11-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-93561
- Event date
- 2025-07-25
- Submission date
- 2025-08-07
- Member states affected
- Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Portugal, Romania, Spain, Netherlands, Poland, Slovakia
- Event description
- See attached report and cover letter
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 459 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol b Synopsis_ATDE_2022-501007-28-00_TC_Redacted | 1 |
| Protocol (for publication) | D1_Protocol track change comparison from JZLH_initial_Redacted | b |
| Protocol (for publication) | D1_Protocol_ EU CT number 2022-501007-28-00_Redacted | e |
| Protocol (for publication) | D1_Protocol_2022-501007-28-00_GR_Redacted | e |
| Protocol (for publication) | D2_Protocol b_TRACK CHANGES_GR_2022-501007-28-00_Redacted | 2 |
| Protocol (for publication) | D4_Study Participant Contact Card_GR | 2 |
| Protocol (for publication) | D6_Statistical Analysis Plan_Redacted | 1 |
| Protocol (for publication) | Justification to collect patients race or ethnicity data_ENG_Redacted | 3.0 |
| Protocol (for publication) | JZLH_Patient Documents Copyright | 2 |
| Protocol (for publication) | Protocol_GR_Redacted | 3 |
| Recruitment arrangements (for publication) | APPT_REM-Crd_GR | 1 |
| Recruitment arrangements (for publication) | APPT_REM-Crd_New_GR | 2 |
| Recruitment arrangements (for publication) | Informed consent_patient recruitment procedure_POL_EN | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment Procedure_ENG_TC | 2 |
| Recruitment arrangements (for publication) | K1_Appreciation Items_V1_san | 1 |
| Recruitment arrangements (for publication) | K1_Emergency_Contact_card_V1_san | 1 |
| Recruitment arrangements (for publication) | K1_Estrategia de reclutamiento | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements _v2_26Jan2023_Clean_san | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements _v2_26Jan2023_TC_san | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Recruitment Brochure_ENG | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_v1 0_14Sep2022_san_ | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_v1_14Sep2022_san_ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Brochure_V1_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Flyer_V1_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Recruitment Brochure_HU | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Recruitment Brochure_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Recruitment Flyer_HU | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Poster_V1_san | 1 |
| Recruitment arrangements (for publication) | K1_RecruitmentArrangements_Recruitment Brochure_RUS | 2 |
| Recruitment arrangements (for publication) | K1_RecruitmentArrangements_Recruitment Brochure_RUS_CoT | 1 |
| Recruitment arrangements (for publication) | K1_Reminder Card_V1_san | 1 |
| Recruitment arrangements (for publication) | K1_Reminder Card_V2_15Aug2023_san | 2 |
| Recruitment arrangements (for publication) | K1_Study Guide | 2 |
| Recruitment arrangements (for publication) | K1_StudyGuide | 1 |
| Recruitment arrangements (for publication) | K1_Thank You Card Screen Fail_V1_san | 1 |
| Recruitment arrangements (for publication) | K1. Recruitment Procedure_ENG | 2 |
| Recruitment arrangements (for publication) | K2 Recruitment Brochure | 1 |
| Recruitment arrangements (for publication) | K2 Website text_NL | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Appointment Reminder Card_V1_PT_PT_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Appointment Reminder Card_V2_PT_PT_san | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Appreciation Items_US_v1_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Brochure_V1_PT_PT_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Emergency_Contact_card_V1_PT_PT_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Flyer_V1_PT_PT_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster_V1_PT_PT_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_StudyGuide | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_StudyGuide_TC | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_StudyGuide_V1_PT_PT_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_StudyGuide_V2_PT_PT_san | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_StudyGuide_V3_15Feb2024_PT_san | 3 |
| Recruitment arrangements (for publication) | K2_Dr_to_Patient_Master_v1_07Sep2022_UK_EN_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Dr_to_Patient_Master_v1_07Sept2022_PT_san_ | 1 |
| Recruitment arrangements (for publication) | K2_Greenphire ClinCard Travel Ref Guide for Subjects_v1_ August 2018_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Greenphire ClinCard Travel Ref Guide for Subjects_v3 0_11Oct 2016_POR_san_ | 3.0 |
| Recruitment arrangements (for publication) | K2_Greenphire Travel Contact Card_v1_August 2018_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Greenphire Travel Contact Card_v2 0 July 2016_POR_san_ | 2.0 |
| Recruitment arrangements (for publication) | K2_Modalidade Recrutamento_CHVNG-E_PT_14Feb2023_red-san | 1 |
| Recruitment arrangements (for publication) | K2_Modalidade Recrutamento_HGO_PT_01Mar2023_red-san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materia_Recruitment_Brochure_Redacted | 2.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appointment Reminder Card | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure master_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GSC_JZLH_Thank You Card_Screen_Failed_V1_08May23_PT_PT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_J2J-MC-JZLH _GP letter_V1_24Jan2023_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study guide | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study guide | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Welcome letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Thank_You_Card_Master_v1_07Sep2022_UK_EN_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Welcome_Letter_Master_v1_07Sep2022_UK_EN_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Welcome_Letter_Master_v1_07Sept2022_PT_san_ | 1 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K3_Recruitment Retention and Other Materials for Subjects | 2 |
| Recruitment arrangements (for publication) | List of paticipating sites_SK_Redacted | 1 |
| Recruitment arrangements (for publication) | List of Planned Sites and Subjects | N/A |
| Recruitment arrangements (for publication) | List of Planned sites and subjects_clean_Redacted | N/A |
| Recruitment arrangements (for publication) | List of Planned sites and subjects_TC | 1.0 |
| Recruitment arrangements (for publication) | List of planned sites_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | List of Planned Sites_ENG_Redacted | 2.0 |
| Recruitment arrangements (for publication) | Patient Card_GR | 2 |
| Recruitment arrangements (for publication) | Recruitment and ICF procedure_CZ | 1 |
| Recruitment arrangements (for publication) | Recruitment and ICF procedure_SK | 1 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure_FRE | 4.0 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure_FRE_TC | 4.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_ENG | 1.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_ENG | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_ENG | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_HU | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_Redacted | 1.0 |
| Recruitment arrangements (for publication) | StudyGuide_GR | 2 |
| Recruitment arrangements (for publication) | Thank_You_Card_GR | 1 |
| Subject information and informed consent form (for publication) | Addendum ICF_Genetic_ICF_HU | 1.1 |
| Subject information and informed consent form (for publication) | Addendum ICF_Optional biopsy_HU | 1 |
| Subject information and informed consent form (for publication) | Addendum ICF_Tissue sample_SK | 1.0 |
| Subject information and informed consent form (for publication) | APPT_REM_Ger | 2 |
| Subject information and informed consent form (for publication) | APPT_REM_GerAT | 1 |
| Subject information and informed consent form (for publication) | APPT_REM_TC_Ger | 2 |
| Subject information and informed consent form (for publication) | Blanket Statement | 1 |
| Subject information and informed consent form (for publication) | Blanket Statement - Document not published anymore_30Nov2023 | 1.0 |
| Subject information and informed consent form (for publication) | ClinCard_Data_Privacy_as_applied_to_GP_RO | 7 |
| Subject information and informed consent form (for publication) | ConneX France Travel Contact Card_FRE | 3 |
| Subject information and informed consent form (for publication) | ConneX France Travel Ref Guide for Subjects_FRE | 3 |
| Subject information and informed consent form (for publication) | Consent Procedure | 1.0 |
| Subject information and informed consent form (for publication) | Consent Procedure_ENG | 1.0 |
| Subject information and informed consent form (for publication) | Diary_CZ | 1 |
| Subject information and informed consent form (for publication) | Diary_SK | 2.0 |
| Subject information and informed consent form (for publication) | Dr to Patient Letter_Ger | 1 |
| Subject information and informed consent form (for publication) | DrToPatient_Ger | 1 |
| Subject information and informed consent form (for publication) | EC Submission Overview_CZ | 7 |
| Subject information and informed consent form (for publication) | EC_packet_w_Data_Privacy_as_applied_to_GP_ENG | 9.0 |
| Subject information and informed consent form (for publication) | Emergency Contact Card_SK | 1 |
| Subject information and informed consent form (for publication) | Emergency_Contact_card_CZ | b |
| Subject information and informed consent form (for publication) | Emergency_Contact_Ger | 1.1 |
| Subject information and informed consent form (for publication) | EmergencyContactCard_Ger | 1 |
| Subject information and informed consent form (for publication) | Fahrtkosten und Aufwandsentschadigung_ger_Redacted | 4 |
| Subject information and informed consent form (for publication) | Fahrtkosten und Aufwandsentschadigung_TC_ger_Redacted | 2 |
| Subject information and informed consent form (for publication) | France_-_EC_packet_w_Data_Privacy_as_applied_to_GP_ENG | 8 |
| Subject information and informed consent form (for publication) | French_France - Greenphire ClinCard Msg Templates - ROW_FRE | 6 |
| Subject information and informed consent form (for publication) | French_France - Greenphire_ClinCard_Cardholder_FAQ_EU_FRE | 3 |
| Subject information and informed consent form (for publication) | French_France - Greenphire_Fee_Schedule_FRE | 4 |
| Subject information and informed consent form (for publication) | French_France_Greenphire_ClinCard_Card_Carrier_EU_FRE | 3 |
| Subject information and informed consent form (for publication) | General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP_ENG | 4 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Msg Templates _RO | 6 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Msg Templates_CZ | 6 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Msg Templates_ger | 1 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Msg Templates_HU | 6 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Msg Templates_PL | 6.0 |
| Subject information and informed consent form (for publication) | Greenphire EC_packet_w_Data_Privacy_HU | 8 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_Carrier_CZ | 4.1 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_Carrier_EU_HU_Redacted | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_Carrier_EU_PL | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_Carrier_EU_RO | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_ger | 1 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_CZ | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_FAQ_EU_HU | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_FAQ_EU_RO | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_ger | 1 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_PL | 3 |
| Subject information and informed consent form (for publication) | Greenphire_Data_Privacy_ger | 1 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule_CZ | 4 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule_ger | 1 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule_HU_Redacted | 4 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule_PL | 4 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule_RO | 4 |
| Subject information and informed consent form (for publication) | Greenphire_Patient Reimbursement Program_Redacted | 1 |
| Subject information and informed consent form (for publication) | Greenphire_Patient Reimbursement Program_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | HIP_Main_SPA_ES_Redacted | 5 |
| Subject information and informed consent form (for publication) | HIP_Main_TC_Redacted | 5 |
| Subject information and informed consent form (for publication) | ICF Addednum_Reimbursement_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF Addednum_Reimbursement_CZ_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF Addendum Optional Biopsy_FRE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF Addendum Optional Biopsy_FRE_TC_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF Addendum Pregnancy_FRE_TC_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF Addendum Pregnant Partner_FRE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF Addendum_Data Privacy_CZ | 1 |
| Subject information and informed consent form (for publication) | ICF Addendum_Tissue sample_CZ | 1 |
| Subject information and informed consent form (for publication) | ICF Adult and Legal Rep_FRE_Redacted | 3 |
| Subject information and informed consent form (for publication) | ICF Adult and Legal Rep_FRE_TC_Redacted | 3 |
| Subject information and informed consent form (for publication) | ICF Sponsor Statement_ENG_redacted | 1.0 |
| Subject information and informed consent form (for publication) | ICF Sponsor Statement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | ICF_Addenda for Participants with Pregnant Partners_ger_redacted | 1 |
| Subject information and informed consent form (for publication) | ICF_Addenda for Pregnant Partners_ger_redacted | 2 |
| Subject information and informed consent form (for publication) | ICF_Data Privacy Addendum_clean | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Data Privacy Addendum_SK | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Data Privacy Addendum_SK_tracked | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Data Privacy Addendum_tracked | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Greenphire_RO_Romanian | 1 |
| Subject information and informed consent form (for publication) | ICF_Pregnant Partner Addendum_SK | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Pregnant Partner_clean | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Pregnant Partner_SK_tracked | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Pregnant Partner_tracked | 1.1 |
| Subject information and informed consent form (for publication) | ICF_RO_English_TC_Redacted | 1 |
| Subject information and informed consent form (for publication) | ICF_TC_ger_Redacted | 3 |
| Subject information and informed consent form (for publication) | J2J-MC-JZLH_GP Letter_ITA_Track Changes_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | JZLH_Addendum Genetic ICF_HU_tc | 1.1 |
| Subject information and informed consent form (for publication) | JZLH_Appreciation Items_US | 1 |
| Subject information and informed consent form (for publication) | JZLH_ICF_10OCT2022_Redacted | 1 |
| Subject information and informed consent form (for publication) | JZLH_ICF_15NOV2022_Redacted | 2 |
| Subject information and informed consent form (for publication) | JZLH_Patient Documents Copyright | 1 |
| Subject information and informed consent form (for publication) | JZLH_Patient information card_HU_printabletc | 3.0 |
| Subject information and informed consent form (for publication) | JZLHALLENJOURNAL | 1 |
| Subject information and informed consent form (for publication) | K2__Recruitment Flyer | 1.0 |
| Subject information and informed consent form (for publication) | K2_APPT_REM-Crd_BEDU | 2.0 |
| Subject information and informed consent form (for publication) | K2_APPT_REM-Crd_BEFR | 2.0 |
| Subject information and informed consent form (for publication) | K2_APPT_REM-Crd_ENG | 2.0 |
| Subject information and informed consent form (for publication) | K2_Emergency_Contact_card_BEDU | 1 |
| Subject information and informed consent form (for publication) | K2_Emergency_Contact_card_BEFR | 1 |
| Subject information and informed consent form (for publication) | K2_Emergency_Contact_card_ENG | 1 |
| Subject information and informed consent form (for publication) | K2_Recruitment Brochure | 1.0 |
| Subject information and informed consent form (for publication) | K2_Recruitment Brochure_BEDU | 1 |
| Subject information and informed consent form (for publication) | K2_Recruitment Brochure_BEFR | 1 |
| Subject information and informed consent form (for publication) | K2_Recruitment Brochure_ENG | 1 |
| Subject information and informed consent form (for publication) | K2_Recruitment Poster | 1.0 |
| Subject information and informed consent form (for publication) | K2_StudyGuide_BEDU | 3.0 |
| Subject information and informed consent form (for publication) | K2_StudyGuide_BEFR | 3.0 |
| Subject information and informed consent form (for publication) | K2_StudyGuide_ENG | 3.0 |
| Subject information and informed consent form (for publication) | Kostenubernahme_Hotel_ger_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ Country ICF main_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_ Country ICF main_Track Changes_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_CountrySpecific_ICF_Main_PT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main IE_V4_16Oct2023_Clean_san_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main IE_V4_16Oct2023_TC_san_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_IE_V1 1_25Jan2023_final clean_san_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_IE_V1 1_25Jan2023_final TC_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_IE_V1 23Sept2022_final clean_san_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_IE_V2_1_14Jul2023_Clean_san_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_IE_V2_1_14Jul2023_TC_san_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_PRT_V1 1_20Jan2023_Clean_PT_Redacted_red-san | 1.1PRT01.1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_PRT_V1 26Sept2022_final clean_TC_20Jan2023_Redacted_red-san | 1.1PRT01.1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_PRT_V1PRT01 26Sept2022_final clean_POR_Redacted_red-san_ | 1PRT01 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_PRT_V2_22Mar2023_PT_red-san | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_PRT_V2_22Mar2023_PT_TC_red-san | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_V4_PRT_V1_12Oct2023_PT_clean_san_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_V4_PRT_V1_12Oct2023_PT_TC_san_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_V5_PRT_V1_11Mar2024_PT_clean_san_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_V5_PRT_V2_06Jun2024_PT_clean_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Preg_PRT_V1 0_20Jan2023_Clean_PT_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Summary of Changes_PT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Summary of Changes_V2A_IE_16Apr2025_EN_Clean_san_redacted | 2A |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Summary of Changes 1_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_J2J-MC-JZLH_Main ICF_V4_1 IE_08Mar2024_Clean_san_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents | 1 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_Part II | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 12.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_TC_DE_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_Recruitment and Informed consent procedure_GR | 2 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_TC_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult _ FRE_TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF IE ENG_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_CZ_SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF SoC_SK_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed consent form Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed consent form Summary of Changes_Redacted | V2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed consent form Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ BEDU_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ BEFR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_CZ_clean_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_DE_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_GER_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RUS_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RUS_v4_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RUS_v6_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_SoC_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_combined_TC _Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement Form_ENG_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement ICF_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement ICF_RUS_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes DUBE_clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes EN_clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes FRBE_clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_ENG_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_RUS_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and_Main ICF_V2 IE_22Mar2023_Clean_san_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and_Main ICF_V2 IE_22Mar2023_TC_san_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Notice Netherlands_NL | 3 |
| Subject information and informed consent form (for publication) | L2_Diary_v1_05Aug2022_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Emergency_Contact_card_SK | 1 |
| Subject information and informed consent form (for publication) | L2_GP Letter_IT_clean_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L2_Info Re-insurance Conditions for Patient_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Appointment reminder card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Appointment reminder card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material StudyGuide | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ APPT_REM_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Dr to Patient Letter_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Participant Information card_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Participant Information card_RUS | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ PK Diary_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ PK Diary_RUS | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Recruitment Brochure_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Recruitment Poster_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Study Guide | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Study Guide_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Thank you Card SF_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Thank you Card_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment reminder card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment reminder card_HU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation items | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Contact_card_HU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dr to Patient Master | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter-Participant-EDC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter-Participant-EDC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter-Participant-STx_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter-Participant-STx_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card_ENG | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card_RUS | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment Flyer_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment Flyer_RUS | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study guide | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study guide _ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study guide_HU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Participant Contact Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Thank You Card_ScreenFail | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank-You-Dropout_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank-You-End-Of-Study_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank-You-Participation_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank-You-Screening_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Participant information card_v1 0_24Aug22_POR_san_ | 1.0 |
| Subject information and informed consent form (for publication) | L2_participant-information-card_v1_26Sep22_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_v1 0_28Sep2022_POR_san_ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Information Overview Letter_v1_25Jan2023_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Information Overview Letter_v1_25Jan2023_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Reimbursement form_DE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Reimbursement form_TC_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention Materials_Study Guide_ENG | 3 |
| Subject information and informed consent form (for publication) | L2_Retention Materials_Study Guide_GER_V3 | 3 |
| Subject information and informed consent form (for publication) | L2_Retention Materials_Study Guide_RUS | 3 |
| Subject information and informed consent form (for publication) | L2_Retention Materials_Study Guide_RUS_CoT | 3 |
| Subject information and informed consent form (for publication) | L2_Study Guide_FRE | 3 |
| Subject information and informed consent form (for publication) | L2_StudyGuide_ATDE | 3 |
| Subject information and informed consent form (for publication) | L2_StudyGuide_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Dropout_Master_PT | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Dropout_Master_v3_24May2024_IE_EN_sanitized | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-End_of_Study_Master_v3_24May2024_IE_EN_sanitized | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-End-Of-Study_Master_PT | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Participation_Master_PT | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Participation_Master_v3_24May2024_IE_EN_sanitized | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Screening_Master_PT | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Screening_Master_v3_24May2024_IE_EN_sanitized | 3 |
| Subject information and informed consent form (for publication) | L2. Patient Emergency Card_NL | 2 |
| Subject information and informed consent form (for publication) | L3_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L3_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L3_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L3_Appreciation items list | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Kolovetsiou-Kreiner | 2 |
| Subject information and informed consent form (for publication) | L3_Patient card_Weiss | 2 |
| Subject information and informed consent form (for publication) | List of ssICF contact details_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | List of submitted documents_Part II_HU | 1 |
| Subject information and informed consent form (for publication) | Main ICF_HU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | Main ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | Main ICF_TC_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | Main ICF_TC_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | Main ICF_TC_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | Main_ICF_CZ_highlighted_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | Main_ICF_CZ_TC_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | Main_ICF_SK_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | Main_ICF_SK_tracked_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | Main_ICF_tracked_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | P1_Appreciation Items_ENG | 2.0 |
| Subject information and informed consent form (for publication) | Participant information card_BEDU | 1 |
| Subject information and informed consent form (for publication) | Participant information card_BEFR | 1 |
| Subject information and informed consent form (for publication) | Participant Information Card_SK | 2.0 |
| Subject information and informed consent form (for publication) | Participant information card_SK | 2.0 |
| Subject information and informed consent form (for publication) | Participant-information-card_CZ | 1 |
| Subject information and informed consent form (for publication) | ParticipantInformationCard_Ger | 1 |
| Subject information and informed consent form (for publication) | Patient card_Bartsch_DE | 1 |
| Subject information and informed consent form (for publication) | Patient card_Denison_DE | 1 |
| Subject information and informed consent form (for publication) | Patient card_Hubalek_DE | 1 |
| Subject information and informed consent form (for publication) | Patient card_Pfeiler_DE | 1 |
| Subject information and informed consent form (for publication) | Patient cards_SPA | 1.1 |
| Subject information and informed consent form (for publication) | Patient Contact Card | N/A |
| Subject information and informed consent form (for publication) | Patient Contact Card_FRE | 1 |
| Subject information and informed consent form (for publication) | Patient Documents Copyright_ENG | 1 |
| Subject information and informed consent form (for publication) | Patient Emergency Card_ENG_FR_NL_DE | 1.0 |
| Subject information and informed consent form (for publication) | Patient Emergency Card_PL | 1 |
| Subject information and informed consent form (for publication) | Patient Information Card_EN_RO | 1 |
| Subject information and informed consent form (for publication) | Patient information card_HU | 3.0 |
| Subject information and informed consent form (for publication) | Patient Information Card_SK | 1 |
| Subject information and informed consent form (for publication) | Patients card_Ger | 2 |
| Subject information and informed consent form (for publication) | Patients card_TC_Ger | 2 |
| Subject information and informed consent form (for publication) | PIL_Anastrozol_SK | 1 |
| Subject information and informed consent form (for publication) | PIL_Anastrozolum_CZ | 1 |
| Subject information and informed consent form (for publication) | PIL_Exemestanum_CZ | 1 |
| Subject information and informed consent form (for publication) | PIL_Exemestanum_SK | 1 |
| Subject information and informed consent form (for publication) | PIL_Letrozol_CZ | 1 |
| Subject information and informed consent form (for publication) | PIL_Letrozol_SK | 1 |
| Subject information and informed consent form (for publication) | PIL_Tamoxifen_CZ | 1 |
| Subject information and informed consent form (for publication) | PIL_Tamoxifen_SK | 1 |
| Subject information and informed consent form (for publication) | Pregnant Participant Consent_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Participant Consent_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Participant Consent_ENG | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner Consent_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner Consent_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner Consent_ENG | 1.0 |
| Subject information and informed consent form (for publication) | Recruitment Brochure_ger | 2 |
| Subject information and informed consent form (for publication) | Recruitment Brochure_SPA | 1.0 |
| Subject information and informed consent form (for publication) | Recruitment Flyer_Ger | 2 |
| Subject information and informed consent form (for publication) | Recruitment Flyer_SPA | 1 |
| Subject information and informed consent form (for publication) | Recruitment Poster_Ger | 1 |
| Subject information and informed consent form (for publication) | Recruitment Poster_SPA | 1 |
| Subject information and informed consent form (for publication) | RecruitmentBrochure_Ger | 1 |
| Subject information and informed consent form (for publication) | RecruitmentFlyer_Ger | 1 |
| Subject information and informed consent form (for publication) | RecruitmentPoster_Ger | 1 |
| Subject information and informed consent form (for publication) | Reservierungsauftragsformular_ger_Redacted | 1 |
| Subject information and informed consent form (for publication) | StudyGuide_Ger | 2 |
| Subject information and informed consent form (for publication) | StudyGuide_Ger | 1 |
| Subject information and informed consent form (for publication) | StudyGuide_TC_ger | 2 |
| Subject information and informed consent form (for publication) | Template - Greenphire EU Generic ClinCard_CZ | 3 |
| Subject information and informed consent form (for publication) | Template - Greenphire EU Generic ClinCard_ENG | 3 |
| Subject information and informed consent form (for publication) | Template - Greenphire EU Generic ClinCard_ENG | 3 |
| Subject information and informed consent form (for publication) | Template - Greenphire EU Generic ClinCard_HU | 3 |
| Subject information and informed consent form (for publication) | Template Greenphire EU Generic ClinCard_ENG | 3 |
| Subject information and informed consent form (for publication) | Thank you card | 1 |
| Subject information and informed consent form (for publication) | Thank You Card_Ger | 1 |
| Subject information and informed consent form (for publication) | Thank_You_Card_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | Thank_You_Card_Master_SK | 1 |
| Subject information and informed consent form (for publication) | ThankYouCard_Ger | 1 |
| Subject information and informed consent form (for publication) | Thuroczy_Remibursement Program_ger_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Letrozole_SmPC_RSI | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol_b_synopsis_ENG_TC_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol_synopsis_ENG_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocl synopsis_SK_2022-501007-28-00_tracked_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol b Synopsis_FR_BE_TC_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis b_ES_2022-501007-28-00_TC_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-501007-28-00_GR_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-501007-28-00_GR_Track Changes_REDACTED | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ATDE_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_b_PL_2022-501007-28-00_track changes_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_DE_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRE_2022-501007-28-00_Redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRE_TC_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Initial A_B_Track Changes_IT_Redacted | B |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2022-501007-28-00_TC_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2022-501007-28-00_TC_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2022-501007-28-00_redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2022-501007-28-00_TC_redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_BE_DU_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_BE_FR_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_NL_BE_TC_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_PL_2022-501007-28-00_Redacted | e |
| Synopsis of the protocol (for publication) | Protocol synopsis_CZ_clean_Redacted | e |
| Synopsis of the protocol (for publication) | Protocol synopsis_CZ_Redacted | a |
| Synopsis of the protocol (for publication) | Protocol synopsis_CZ_track changes_Redacted | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis_ger_Redacted | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_HU_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | Protocol Synopsis_POR_Redacted | Initial |
| Synopsis of the protocol (for publication) | Protocol synopsis_SK_Redacted | e |
Application history
29 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-26 | Belgium | Acceptable 2023-03-03
|
2023-03-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-04-24 | Acceptable 2023-03-03
|
2023-04-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-05-31 | Belgium | Acceptable 2023-09-04
|
2023-09-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-10 | Belgium | Acceptable 2024-03-04
|
2024-03-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-08 | Belgium | Acceptable with conditions 2024-07-15
|
2024-07-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-09 | Belgium | Acceptable 2024-11-08
|
2024-11-08 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-02 | Acceptable | 2025-01-31 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-13 | Acceptable | 2025-02-25 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-26 | Belgium | Acceptable 2025-05-19
|
2025-05-20 |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-06-12 | Acceptable | 2025-07-18 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-09-23 | Acceptable | 2025-10-23 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-09-23 | Acceptable | 2025-11-10 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-09-24 | Acceptable | 2025-10-20 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-09-24 | Acceptable | 2025-12-05 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-23 | 2025-09-25 | Acceptable | 2025-10-08 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-09-29 | Acceptable | 2025-11-12 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-09-29 | Acceptable | 2025-11-13 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-09-29 | Acceptable | 2025-11-10 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-09-30 | Acceptable | 2025-11-18 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-09-30 | Acceptable | 2025-11-24 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-09-30 | Acceptable | 2025-10-29 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-09-30 | Acceptable | 2025-11-17 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-09-30 | Acceptable | 2025-11-17 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-24 | 2025-09-30 | Acceptable | 2025-11-28 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-26 | 2025-10-01 | Belgium | Acceptable | 2025-10-30 |
| 26 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-08 | Belgium | Acceptable | 2025-12-08 |
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-08 | Acceptable | 2025-12-08 | |
| 28 | SUBSTANTIAL MODIFICATION | SM-27 | 2026-01-16 | Belgium | Acceptable 2026-04-20
|
2026-04-20 |
| 29 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-04-28 | Acceptable 2026-04-20
|
2026-04-28 |