Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
293
Countries
14
Sites
76
idiopathic pulmonary fibrosis
The primary objectives are to demonstrate a non-flat dose response curve, evaluate the quantitative treatment effect size and evaluate the dose-response relationship of 3 different doses of BI 1819479 versus placebo.
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 10 Sep 2024 → 16 Jan 2026
- Decision date (initial)
- 2024-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508395-11-00
- WHO UTN
- U1111-1302-4283
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The primary objectives are to demonstrate a non-flat dose response curve, evaluate the quantitative treatment effect size and evaluate the dose-response relationship of 3 different doses of BI 1819479 versus placebo.
Secondary objectives 1
- The secondary objective is to evaluate the efficacy by comparing the difference in disease progression in terms of FVC decline (absolute change from baseline in FVC at Week 24) for 3 different doses of BI 1819479 and placebo.
Conditions and MedDRA coding
idiopathic pulmonary fibrosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Patients ≥40 years old at the time of signed informed consent.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guidelines
- On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not on treatment with either nintedanib or pirfenidone for at least 12 weeks
- Forced Vital Capacity (FVC) ≥45% of predicted normal.
- DLCO ≥25% of predicted normal corrected for hemoglobin (Hb).
- Women of childbearing potential (WOCBP) must use highly effective methods of birth control with low user dependency and additional barrier contraception for male partners (use of condom) until end of follow-up period.
- Male trial participants with WOCBP partners must use contraception (condom) to avoid exposure via seminal fluid. Female partners of male trial participants must use highly effective methods of contraception during treatment until end of follow-up period.
Exclusion criteria 7
- Acute IPF exacerbation within at least 12 weeks and/or during the screening period
- Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone >15 mg/day or equivalent for respiratory or pulmonary reasons.
- Patients with a significant disease or condition other than the IPF under study, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with trial procedures, or cause concern regarding the patient’s ability to participate in the trial or any medical condition which could lead to a life expectancy <12 months.
- Relevant airways obstruction (pre-bronchodilator FEV1/FVC <0.7).
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Lower respiratory tract infection requiring treatment within 4 weeks and/or during the screening period
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Annual rate of decline in FVC [mL/year] assessed over a treatment period up to a maximum of 52 weeks
Secondary endpoints 1
- Absolute change from baseline in FVC at Week 24 [in mL]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11140905 · Product
- Active substance
- BI 1819479
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD11140902 · Product
- Active substance
- BI 1819479
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12 |
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
14 EU/EEA countries · 76 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 7 |
| Belgium | Ended | 8 | 3 |
| Czechia | Ended | 4 | 2 |
| Denmark | Ended | 4 | 2 |
| Finland | Ended | 6 | 5 |
| France | Ended | 14 | 9 |
| Germany | Ended | 20 | 12 |
| Greece | Ended | 5 | 3 |
| Hungary | Ended | 5 | 2 |
| Italy | Ended | 18 | 9 |
| Norway | Ended | 5 | 3 |
| Poland | Ended | 6 | 6 |
| Spain | Ended | 18 | 11 |
| Sweden | Ended | 6 | 2 |
| Rest of world
Japan, Canada, Thailand, Korea, Republic of, New Zealand, United States, Malaysia, Taiwan, Brazil, Singapore, Australia, China, Argentina, United Kingdom
|
— | 170 | — |
Investigational sites
Stadt Wien Wiener Gesundheitsverbund
Abteilung für Atemwegs- und Lungenkrankheiten, Baumgartner Hoehe 1, Penzing, Vienna
Medical University Of Graz
Klinische Abteilung f. Pulmonologie, Neue Stiftingtalstrasse 6, 8010, Graz
Ordensklinikum Linz GmbH
Pulmonology, Fadingerstrasse 1, 4020, Linz
Universitaetsklinikum Krems
Department for Pneumology, Mitterweg 10, 3500, Krems An Der Donau
Johannes Kepler University Linz
University Clinic for Internal Medicine 4, Med Campus III, Med Campus III, Krankenhausstrasse 9, Linz
Stadt Wien Wiener Gesundheitsverbund
Clinic for Internal Med.and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Klinikum Wels-Grieskirchen GmbH
Pneumol., Grieskirchner Strasse 42, 4600, Wels
Centre Hospitalier Regional De La Citadelle
n/a, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Pulmonary Medicine, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre hospitalier universitaire de Liege
Pneumology-Allergology, Avenue De L'hopital 1, 4000, Liege
Fakultni Thomayerova nemocnice
Dept of Respiratory Medicine, First Faculty of Medicine,, Videnska 800, Krc, Prague 4
Fakultni Nemocnice Bulovka
Deparment of Pulmonary disease and tuberculosis, Budinova 67/2, Liben, Prague
Rigshospitalet
Afsnit for Lungetransplantation og lunge sygdomme, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Odense University Hospital
Lungemedicinsk afdeling J, J B Winsloews Vej 4, 5000, Odense C
Tampere University Hospital
Tutkimuspalvelut, Tutkimusvastaanotto, Biokatu 10, 33520, Tampere
Kuopio University Hospital
keuhkopoliklinikka, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
HUS-Yhtymae
Biomedicum Helsinki 2C, P. O. Box 705, 00029, Helsinki
Turku University Hospital
keuhkosairauksien palvelualue, Hameentie 11, 20520, Turku
Pohjois-Pohjanmaan hyvinvointialue
neurologian tutkimusyksikkö, Kajaanintie 50, 90220, Oulu
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire Rouen
Service de Pneumologie, Oncologie thoracique et Soins intensifs respiratoires, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Lille
Service Pneumo Immuno Allergologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire De Caen Normandie
Centre de Recherche Clinique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Nice
Service de Pneumologie, 30 Voie Romaine, 06000, Nice
Assistance Publique Hopitaux De Paris
Unité de Médecine Ambulatoire Pair Pneumologie, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire D'Angers
Service de Pneumologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Rennes
Centre Cardio-Pneumologique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Regional De Marseille
Service de Pneumologie - Maladies Rares Respiratoires, 265 Chemin Des Bourrely, 13015, Marseille
Lungenfachklinik Immenhausen
Fachklinik für Lungenerkrankungen, Robert-Koch-Str. 3, 34376, Immenhausen
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik II, Venusberg-Campus 1, Venusberg, Bonn
Klinikum Region Hannover GmbH
Klinik für Pneumologie, Intensiv- und Schlafmedizin, Stadionbruecke 6, Linden-Sued, Hanover
Klinikum Konstanz GmbH
II. Medizinische Klinik, Mainaustrasse 35, Petershausen, Konstanz
Charite Universitaetsmedizin Berlin KöR
Klinik für Pneumologie, Beatmungsmedizin, Chariteplatz 1, Mitte, Berlin
Universitaetsmedizin Greifswald KöR
Klinik und Poliklinik für Innere Medizin II - Pneumologie/Infektiologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Pneumologische Praxis Dr. Löh
n/a, Saalburgstr. 155, 61350, Bad Homburg
Klinikum Fulda gAG
Herz-Thorax-Zentrum Fulda, Medizinische Klinik V, Pneumologie, Pacelliallee 4, Ziehers-Sued, Fulda
Universitaet Leipzig
Universitätsmedizin Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik V, Marchioninistrasse 15, Hadern, Munich
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Zentrum für Pneumologie und Thoraxchirurgie, Theo-Funccius-Strasse 1, 58675, Hemer
Caritas Krankenhaus St. Maria gGmbH
Studienambulanz, Ludwigstrasse 68, 93093, Donaustauf
General University Hospital Of Patras
Department of Internal Medicine, Pneumonology Clinic, Rio, 265 04, Patras
University General Hospital Of Heraklion
Pulmonary Department, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Ioannina
Respiratory Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University Of Debrecen
Pulmonology Clinic, Nagyerdei Korut 98, 4032, Debrecen
Orszagos Koranyi Pulmonologiai Intezet
IV. Pulmonology Department, Koranyi Frigyes Ut 1, 1121, Budapest XII
Azienda Ospedaliero Universitaria Ospedali Riuniti
Pneumologia 4, Viale Luigi Pinto 1, 71122, Foggia
IRCCS Ospedale Policlinico San Martino
Interventional Pulmonoligist, Largo Rosanna Benzi 10, 16132, Genoa
Multimedica S.p.A.
UO pneumologia, Via San Vittore 12, 20123, Milan
Careggi University Hospital
Pneumologia Interventistica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Sant Andre
U.O.C. Pneumologia, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Malattie Respiratorie - Dipartimento Medicina Interna, Viale Oxford 81, 00133, Rome
Azienda Ospedaliera di Padova
U.O. Pneumologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Unita Sanitaria Locale Della Romagna
Dipartimento Toracico - AUSL di Forlì, Via Carlo Forlanini 34, 47121, Forli'
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Pneumologia, Largo Francesco Vito 1, 00168, Rome
Akershus University Hospital
Lungeavdelingen, Sykehusveien 27, 1478, Lorenskog
Oslo University Hospital HF
Lungeavdelingen, Sognsvannsveien 20, 0372, Oslo
Helse Bergen HF
Lungepoliklinikken, forskning, Jonas Lies Vei 65, 5021, Bergen
Uniwersytecki Szpital Kliniczny W Bialymstoku
First Clinic of Lung Diseases, Lung Cancer and Internal Diseases, Zurawia 14, 15-540, Bialystok
Uniwersytecki Szpital Kliniczny W Poznaniu
Department of Pulmonology, Allergology and Pulmonary Oncology, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
National Institute Of Tuberculosis And Lung Diseases
1st Department of Lung Diseases, Ul. Plocka 26, 01-138, Warsaw
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Dept of Internal Medicine, Pulmonary Diseases and Allergy, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Practice, Ul. Kolejowa 3, 21-040, Swidnik
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Pulmonology and Allergology Clinical Department, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz
Hospital De Galdakao Usansolo
Servicio de Neumología, Leku Barrio Labeaga 46 A, 48960, Galdakao
University Hospital Virgen Del Rocio S.L.
Servicio de Neumología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
Servicio de Neumología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Infanta Leonor
Servicio de Neumología, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario De La Princesa
Servicio de Neumología, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Virgen De La Victoria
Servicio de Neumología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Central De Asturias
Servicio de Neumología, Avenida De Roma S/n, 33011, Oviedo
Bellvitge University Hospital
Servicio de Neumología, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Servicio de Neumología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Marques De Valdecilla
Servicio de Neumología, Avenida Valdecilla Sn, 39008, Santander
Hospital General Universitario Dr. Balmis
Servicio de Neumología, Avinguda Del Pintor Baeza 12, 03010, Alicante
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 | 2024-10-21 | 2026-01-09 | 2024-11-14 | 2025-04-30 | |
| Belgium | 2024-10-07 | 2026-01-06 | 2024-11-12 | 2025-04-30 | |
| Czechia | 2024-11-01 | 2026-01-08 | 2024-11-15 | 2025-04-30 | |
| Denmark | 2024-10-21 | 2026-01-08 | 2025-01-30 | 2025-04-30 | |
| Finland | 2024-09-10 | 2026-01-09 | 2024-11-18 | 2025-04-30 | |
| France | 2024-09-13 | 2026-01-13 | 2024-12-13 | 2025-04-30 | |
| Germany | 2024-10-01 | 2026-01-09 | 2024-11-13 | 2025-04-30 | |
| Greece | 2025-01-13 | 2026-01-08 | 2025-01-22 | 2025-04-30 | |
| Hungary | 2024-10-28 | 2026-01-12 | 2025-02-12 | 2025-04-30 | |
| Italy | 2024-10-21 | 2026-01-09 | 2025-01-15 | 2025-04-30 | |
| Norway | 2024-10-23 | 2026-01-08 | 2025-01-14 | 2025-04-30 | |
| Poland | 2025-01-07 | 2026-01-07 | 2025-03-06 | 2025-04-30 | |
| Spain | 2024-09-17 | 2026-01-12 | 2024-10-10 | 2025-04-30 | |
| Sweden | 2024-09-25 | 2026-01-07 | 2024-12-16 | 2025-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 537 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_EU Protocol Amendment 2023-508395-11-00-GR | 2 |
| Protocol (for publication) | D1_EU Protocol Amendment 2023-508395-11-00-public | 2 |
| Protocol (for publication) | D1_Protocol 2023-508395-11-00-GR-public | 1 |
| Protocol (for publication) | D1_Protocol 2023-508395-11-00-public | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-paper-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshot-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshots-english-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshots-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-screenshots-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-training-module-opt-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-c-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-s-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-c-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-s-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-c-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-s-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-optional-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-s-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-quest-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-impact-of-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgic-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgic-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgic-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgic-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgic-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-tablet-pgic-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-c-impact-of-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-s-impact-of-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-paper-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-training-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-training-optional-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-eq-5d-5l-digital | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-eq-5d-5l-paper | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-overall-symptoms-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-diary-polish-medication | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-optional-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-c-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-s-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-eq-5d | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-impact-on-daily-life | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-eq-5d-5l | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-lpf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-lpf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgic-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgic-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgic-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgic-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgic-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgic-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgis-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgis-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgis-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgis-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pgis-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-questionnaire-screenshots-eng-pigs-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-effective-eq-5d-5l-digital-self-complete | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-eq-5d-5l-paper | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-shortness-of-breath | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-overall-health-status | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-overall-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-shortness-of-breath | 1 |
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| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FR-additional document-public | 1 |
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| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-IT-placeholder | 1 |
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| Recruitment arrangements (for publication) | k1_recruitment-arrangements-fr-adv-poster | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-fr-adv-study-flyer | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-AT-adv-clinlife-ec-notes-study-listing-placeholder | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-AT-adv-ec-doc-study-details-placeholder | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-AT-clinic-wall-poster-translation-placeholder | 1 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-BE-adv-eng-clinical-trial-flyer | 3 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-BE-adv-poster-eng | 2 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-CZ-adv-clinlife-ec-notes-study-listing-v-01-placeholder | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-CZ-adv-clinlife-ec-notes-study-listing-v-03-placeholder | 3 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-FI-fin-newspaper | 2 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-FI-swe-adv-poster | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-FI-swe-adv-poster-layout | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-FI-swe-study-flyer | 4 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-FI-swe-study-flyer-layout | 4 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-HU-flyer-placeholder | 4 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-IT-italian-clinic-wall-poster-placeholder | 1 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-IT-italian-study-flyer-placeholder | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-adv-clinlife-ec-notes-study-listing | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-adv-clinlife-ec-notes-study-listing-3 | 3.3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-clinic-wall-poster | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-study-flyer | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-study-flyer-SE | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-wall-poster-SE | 3 |
| Recruitment arrangements (for publication) | k2_recruitment-material-at-clinic-wall-poster | 2 |
| Recruitment arrangements (for publication) | k2_recruitment-material-at-study-flyer | 3 |
| Recruitment arrangements (for publication) | k2_recruitment-material-de-clinical-poster | 3 |
| Recruitment arrangements (for publication) | k2_recruitment-material-de-study-flyer | 4 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-diary-medication | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-eq-5d-5l | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-l-pf-impacts | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-l-pf-symptoms | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-c-cough | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-c-fatigue | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-c-impact-on-daily-life | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-c-overall-health-status | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-c-overall-symptoms | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-c-shortness-of-breath | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-s-cough | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-s-fatigue | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-s-impact-on-daily-life | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-s-overall-health-status | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-s-overall-symptoms | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-pgi-s-shortness-of-breath | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-eq-5d | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-l-pf-impacts | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-l-pf-symptoms | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-optional-training-ecoa-tablet | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-c-cough | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-c-fatigue | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-c-impact-on-daily-life | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-c-overall-health-status | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-c-overall-symptoms | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-c-shortness-of-breath | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-s-cough | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-s-fatigue | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-s-impact-on-daily-life | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-s-overall-health-status | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-s-overall-symptoms | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-pgi-s-shortness-of-breath | 1 |
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| Subject information and informed consent form (for publication) | L1_ ICF-AT-biobanking | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-AT-main-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-AT-optional-caregiver | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-AT-optional-hrct-scans | 2 |
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| Subject information and informed consent form (for publication) | L1_ ICF-AT-pregnant-partner | 2 |
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| Subject information and informed consent form (for publication) | L1_ ICF-BE-dutch-caregiver-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-dutch-hrct-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-dutch-main-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-dutch-pregnant-partner-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-english-biobanking-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-english-caregiver-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-english-hrct-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-english-main-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-english-main-sponsor-statement | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-english-pregnant-partner-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-french-biobanking-public | 1 |
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| Subject information and informed consent form (for publication) | L1_ ICF-BE-french-hrct-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-french-main-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-french-pregnant-partner-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-DE-ger | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-caregiver-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ-biobanking | 2 |
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| Subject information and informed consent form (for publication) | L1_ ICF-CZ-hrct | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ-main-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ-optional-caregiver | 2 |
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| Subject information and informed consent form (for publication) | L1_ ICF-FI-main-appendix-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-FI-main-public | 4 |
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| Subject information and informed consent form (for publication) | L1_ ICF-FR-french-caregiver | 1 |
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| Subject information and informed consent form (for publication) | L1_ ICF-FR-french-main-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-FR-french-optional-biobanking-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-FR-french-optional-hrct-public | 1 |
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| Subject information and informed consent form (for publication) | L1_ ICF-FR-french-pregnant-partner-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-hrct-DE-ger | 2 |
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| Subject information and informed consent form (for publication) | L1_ ICF-HU-hungarian-pregnant-partner | 2 |
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| Subject information and informed consent form (for publication) | L1_ ICF-IT-italian-optional-biobanking-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-IT-italian-optional-caregiver | 1 |
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| Subject information and informed consent form (for publication) | L1_ ICF-IT-italian-optional-travel-services | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-IT-italian-pregnant-partner | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-DE-ger-public | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-SE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-newborn-DE-ger-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-optional-hrct-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-PL-polish-biobanking | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-PL-polish-caregiver | 1-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-PL-polish-hrct-version | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-PL-polish-main-public | 3-4 |
| Subject information and informed consent form (for publication) | L1_ ICF-PL-polish-pregnant-partner | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-DE-ger-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-travel-services-SE | 1 |
| Subject information and informed consent form (for publication) | l1_icf-at-pregnant-subject | 1 |
| Subject information and informed consent form (for publication) | l1_icf-be-dutch-travel-service | 1 |
| Subject information and informed consent form (for publication) | l1_icf-be-eng-travel-service | 1 |
| Subject information and informed consent form (for publication) | l1_icf-be-french-travel-service | 1 |
| Subject information and informed consent form (for publication) | l1_icf-de-reconsent | 4 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-english-retention-item-patient-folder | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-feedback-questionaire | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-participant-end-drop-out | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-participant-not-joining | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-participant-start-middle | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-patient | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-screen-middle | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-screens-decline | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-screens-drop | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-experience-survey-screens-end | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-trial-experience-survey-screen-start | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-trial-id-card-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-HU-diary-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-HU-list-submitted-docs | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-HU-patient-folder | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-HU-trial-id-card-letter | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-HU-trial-id-card-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-IT-trial-id-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-PL-diary-polish-medication | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-PL-retention-item-patient-folder | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-PL-trial-id-card-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-AT-eu-ctr-list-of-sites | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-mock-up-design-DE-ger | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-process-description-DE-ger | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject-info-AT-trial-id-card-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-it-travel-contact-card | 10 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-it-travel-data-protection | 10 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-it-travel-guide | 10 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary 2023-508395-11-00-IT-public | 3 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary-AT- 2023-508395-11-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ AT-ger-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ BE-dut-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ BE-fre-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ BE-ger-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ CZ-cze-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ DE-ger-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ DK-dan-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ english-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ ES-spa-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ FI-fin-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ FI-swe-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ FR-fre-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ GR-gre-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ HU-hun-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ IT-ita-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ NO-nor-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ PL-pol-2023-508395-11-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ SE-swe-2023-508395-11-00 | 1 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Germany | Acceptable 2024-08-29
|
2024-08-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-25 | Acceptable 2024-08-29
|
2024-10-25 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-03 | Acceptable | 2025-02-03 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-03 | Acceptable | 2025-01-27 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-03 | Acceptable | 2025-01-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-03 | Germany | Acceptable | 2025-02-03 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-03 | Acceptable | 2025-01-15 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-03 | Acceptable | 2024-12-20 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-03 | Acceptable | 2025-01-24 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-03 | Acceptable | 2025-01-21 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-12-03 | Acceptable | 2025-01-27 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-03 | Acceptable | 2025-01-29 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-05-20 | Acceptable | 2025-07-03 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-03 | Germany | Acceptable | 2025-07-03 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-22 | Acceptable | 2025-12-22 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-01-19 | Acceptable | 2026-02-24 |