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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000392-28 | EudraCT Number |
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Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib | Experimental | patient receives capsules containing nintedanib twice a day |
|
| Placebo | Placebo Comparator | patient receives capsules identical to those containing active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks | Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate. | up to week (wk) 52 after the start of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52 | This is the first key secondary endpoint. The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41107055 | Derived | Smith V, Denton CP, Herrick AL, Ittrich C, Alves M, Cutolo M. Nailfold capillaroscopy in patients with systemic sclerosis-associated interstitial lung disease: a substudy of the SENSCIS trial. RMD Open. 2025 Oct 17;11(4):e005704. doi: 10.1136/rmdopen-2025-005704. | |
| 40233987 | Derived | Volkmann ER, Assassi S, Denton CP, Simonovska R, Sambevski S, Alves M, Bernstein EJ. Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease Based on Serological Profiles With a Focus on Anticentromere and Anti-RNA Polymerase III Antibodies. J Rheumatol. 2025 Sep 1;52(9):914-918. doi: 10.3899/jrheum.2024-1063. |
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated
This was a randomised, placebo-controlled, double-blind, parallel design trial.
Abbreviation used:
treatment (trt) baseline (bl.) categorical (cat.) continuous (cont.) number (no.) patient (pt) Placebo (pl.) discontinued (disc.) primary analysis (PA) Antitopoisomerase Antibody (ATA)
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. |
| FG001 | Nintedanib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2018 | Oct 28, 2019 |
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|
| Baseline and up to 52 weeks after the start of administration |
| Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52. | This is the second key secondary endpoint. The Saint George's Respiratory Questionnaire measures the health status in patients with chronic airflow limitation. It consists of 2 parts that cover 3 domains: symptoms, activities, and impacts. The symptom domain relates to the effect, frequency and severity of respiratory symptoms. The activity domain relates to activities that cause or are limited by breathlessness. The impact domain evaluates a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. The scores of these domains range from 0 (no impairment) to 100 (worst possible). The calculated total score summarises the impact of the disease on overall health status. A high score corresponds to worse health. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Baseline and up to 52 weeks after the start of administration |
| Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks | Annual rate of decline in FVC in percentage (%) predicted over 52 weeks. For this endpoint reported means represent the adjusted rate. | up to 52 weeks after the start of administration |
| Absolute Change From Baseline in FVC in mL at Week 52 | Absolute change from baseline in FVC in mL at Week 52. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Baseline and up to 52 weeks after the start of administration |
| Relative Change From Baseline [%] of mRSS at Week 52 | Relative change from baseline [%] of mRSS at Week 52. The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Baseline and up to 52 weeks after the start of administration |
| Time to Death | Time to event analysis of patients with death. The number of observed patients with death are reported. | From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks) |
| The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52 | The percentage (%) of responder based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52. This is a composite endpoint, based on the mRSS, FVC percent predicted, HAQ-DI, patient's global impression of overall health Visual Analogue Scale (VAS) and physician's global impression of patient's overall health VAS, as well as the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension. The CRISS index score represents a probability of improvement and ranges between 0 and 1. This is a 2 stage process to predict probability of improvement: Step 1 - absence of major organ progression (SRC etc.) - score "0" Step 2 - predicted probability of improvement - (score "0 - 1") | Week 52 |
| Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52 | Absolute change from baseline in Carbon Monoxide Diffusion Capacity (DLco) in % predicted at Week 52. Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Baseline and up to 52 weeks after the start of administration |
| Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52 | Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) at Week 52. It is calculated at a visit by counting the total number of fingertips with ulcers (i.e. number of fingers with presence of digital ulcer ticked "Yes") at the corresponding visit Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Baseline and up to 52 weeks after the start of administration |
| Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 | Absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52. The HAQ-DI score is calculated as follows: Each question is scored 0-3 (where 0= "without difficulty" & 3= "unable to do"). There are 8 categories (Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities), each including 2 or 3 questions. The score for each category corresponds to maximum question score within each category. Finally, HAQ-DI score corresponds to sum of the sub-scores of all 8 categories divided by number of categories completed. Please note that if there are fewer than 6 categories with responses, then a score cannot be calculated. The HAQ-DI score scale has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). A high score corresponds to worse impairment. Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Baseline and up to 52 weeks after the start of administration |
| Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52 | Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) dyspnoea score at Week 52. FACIT-Dyspnoea (Dyspnoea) 10 Item Short Form include a 4-point rating scale (no shortness of breath=0; mildly short of breath=1; moderately short of breath = 2; severely short of breath =3; or I did not do this in the past 7 days =4). A raw score is calculated as: Sum individual item scores * 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. FACIT dyspnea scale score ranges between 0 and 75.9. The FACIT-Dyspnea short forms are scored such that a high score represents high levels of dyspnea. Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Baseline and up to 52 weeks after the start of administration |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California Davis | Sacramento | California | 95817 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5236 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | United States |
| University of Miami | Miami | Florida | 33125 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic-Rochester | Rochester | Minnesota | 55905 | United States |
| The Lung Research Center, LLC | Chesterfield | Missouri | 63017 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Health | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of South Carolina | Columbia | South Carolina | 29203 | United States |
| Vanderbilt Pulmonary Clinic | Nashville | Tennessee | 37232-5735 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University Of Texas at Houston | Houston | Texas | 77030 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich | Buenos Aires | C1426BOR | Argentina |
| APRILLUS-Asistencia e Investigación | Ciudad Autonoma Buenos Aires | C1046AAQ | Argentina |
| CEMER-Centro Medico De Enfermedades Respiratorias | Florida | B1602DQD | Argentina |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Liverpool Hospital | Sydney | New South Wales | 2170 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| LKH-Univ. Hospital Graz | Graz | 8036 | Austria |
| Medical University of Innsbruck | Innsbruck | 6020 | Austria |
| ULB Hopital Erasme | Brussels | 1070 | Belgium |
| Brussels - UNIV Saint-Luc | Brussels | 1200 | Belgium |
| UNIV UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| Edumed - Educacao e Saude SA | Curitiba | 80440-080 | Brazil |
| Saint Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5T 3L9 | Canada |
| HSCM | Montreal | Quebec | H4J 1C5 | Canada |
| Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente" | Concepción | 4070038 | Chile |
| Centro de Investigación del Maule | Talca | 3465586 | Chile |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| Beijing Chao-Yang Hospital | Beijing | China |
| Beijing Hospital | Beijing | China |
| First Hospital of Jilin University | Changchun | China |
| West China Hospital | Chengdu | 610041 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | 230022 | China |
| Huashan Hospital, Fudan University | Shanghai | 200040 | China |
| The First Hospital of Chinese Medical University | Shenyang | China |
| Zhuzhou Central Hospital | Zhuzhou | 412007 | China |
| Institute of Rheumathology Prague | Prague | 12850 | Czechia |
| Thomayer Hospital | Prague | 14059 | Czechia |
| Aarhus Universitets Hospital | Aarhus | 8000 | Denmark |
| Odense Universitetshospital | Odense | 5000 C | Denmark |
| HYKS Keuhkosairauksien | Helsinki | 00290 | Finland |
| TYKS, Keuhkosairauksien klinikka, Turku | Turku | 20520 | Finland |
| HOP Avicenne | Bobigny | 93009 | France |
| HOP Louis Pradel | Bron | 69677 | France |
| HOP Calmette | Lille | 59037 | France |
| HOP Claude Huriez | Lille | 59037 | France |
| HOP Arnaud de Villeneuve | Montpellier | 34295 | France |
| HOP Hôtel-Dieu | Nantes | 44000 | France |
| HOP Pasteur | Nice | 06001 | France |
| HOP Cochin | Paris | 75014 | France |
| HOP Bichat | Paris | 75018 | France |
| HOP Pontchaillou | Rennes | 35033 | France |
| HOP Charles Nicolle | Rouen | 76000 | France |
| HOP Larrey | Toulouse | 31059 | France |
| HOP Bretonneau | Tours | 37044 | France |
| Kerckhoff-Klinik, Bad Nauheim | Bad Nauheim | 61231 | Germany |
| Universitätsklinikum Köln (AöR) | Cologne | 50937 | Germany |
| Klinik Donaustauf | Donaustauf | 93093 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Klinikum der Universität München - Campus Großhadern | München | 80336 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| General Hospital of Athens "Laiko" | Athens | 115 27 | Greece |
| General Hospital of Athens "Laiko" | Athens | 11527 | Greece |
| Semmelweis University, Dept. Pulmonology | Budapest | 1125 | Hungary |
| St John's Medical College | Bangalore | 560 034 | India |
| Ramaiah Medical College and Hospitals | Bangalore | 560054 | India |
| Mazumdar Shaw Medical centre | Bangalore | 560099 | India |
| Postgraduate Institute of Medical Education And Research | Chandigarh | 160012 | India |
| Care Hospital | Hyderabad | 500034 | India |
| Nizam's Institute of Medical Sciences | Hyderabad | 500082 | India |
| Asthma Bhawan | Jaipur | 302039 | India |
| P.D. Hinduja National Hospital | Mumbai | 400016 | India |
| Getwell Hospital & Research Institute | Nagpur | 440012 | India |
| All India Institute of Medical Science | New Delhi | 110029 | India |
| Sir Gangaram Hospital | New Delhi | 110060 | India |
| Jehangir Clinical Development Centre Pvt. Ltd. | Pune | 411 001 | India |
| B.J. Medical College and Sasoon General Hospital | Pune | 411001 | India |
| Inamdar Multispeciality Hospital | Pune | 411040 | India |
| Christian Medical College | Vellore | 632 004 | India |
| Cork University Hospital | Cork | Ireland |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| Bnei Zion Medical Center, Haifa | Haifa | 31048 | Israel |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Rabin Medical Center Beilinson | Petah Tikva | 49100 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Az. Ospedaliere Umberto I di Ancona | Ancona | 60126 | Italy |
| Università degli Studi di Genova | Genova | 16132 | Italy |
| A.O. San Gerardo di Monza | Monza | 20900 | Italy |
| A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli | Naples | 80138 | Italy |
| Università degli Studi Padova | Padova | 35128 | Italy |
| Azienda Universitaria-Universita' La Sapienza | Roma | 00161 | Italy |
| Tosei General Hospital | Aichi, Seto | 489-8642 | Japan |
| Kurume University Hospital | Fukuoka, Kurume | 830-0011 | Japan |
| Sapporo Medical University Hospital | Hokkaido, Sapporo | 060-8543 | Japan |
| National Hospital Organization Himeji Medical Center | Hyogo, Himeji | 670-8520 | Japan |
| Iwate Medical University Hospital | Iwate, Morioka | 020-8505 | Japan |
| St. Marianna University School of Medicine Hospital | Kanagawa, Kawasaki | 216-8511 | Japan |
| Kitasato University Hospital | Kanagawa, Sagamihara | 252-0375 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | 236-0051 | Japan |
| Kyoto University Hospital | Kyoto, Kyoto | 606-8507 | Japan |
| Nagasaki University Hospital | Nagasaki, Nagasaki | 852-8501 | Japan |
| Kindai University Hospital | Osaka, Osakasayama | 589-8511 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | 591-8555 | Japan |
| Osaka Medical College Hospital | Osaka, Takatsuki | 569-8686 | Japan |
| Saitama Medical University Hospital | Saitama, Iruma-gun | 350-0495 | Japan |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
| Tokushima University Hospital | Tokushima, Tokushima | 770-8503 | Japan |
| Juntendo University Hospital | Tokyo, Bunkyo-Ku | 113-8431 | Japan |
| Nippon Medical School Hospital | Tokyo, Bunkyo-Ku | 113-8603 | Japan |
| Toho University Omori Medical Center | Tokyo, Ota-ku | 143-8541 | Japan |
| Institute of Rheumatology Tokyo Women's Medical University | Tokyo, Shinjyuku-ku | 162-0054 | Japan |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Selayang | Kuala Selangor | 68100 | Malaysia |
| Hospital Pulau Pinang | Pulau Pinang | 10990 | Malaysia |
| Hospital Tuanku Ja'afar | Seremban | 70300 | Malaysia |
| Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas | Mexico City | 14080 | Mexico |
| VU Medisch Centrum | Amsterdam | 1081HV | Netherlands |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | 2333 ZA | Netherlands |
| Radboud Universitair Medisch Centrum | Nijmegen | 6525 GA | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CE | Netherlands |
| Oslo Universitetssykehus HF, Rikshospitalet | Oslo | N-0372 | Norway |
| Universitetssykehuset Nord-Norge, Tromsø | Tromsø | N-9038 | Norway |
| Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz | Bydgoszcz | 85168 | Poland |
| Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow | Krakow | 31011 | Poland |
| EMED, Center of Medical Services,Private Prac,Rzeszow | Rzeszów | 35205 | Poland |
| Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw | Wroclaw | 50 368 | Poland |
| Hospital Garcia de Orta, EPE | Almada | 2801-951 | Portugal |
| Hospital Fernando Fonseca, EPE | Amadora | 2720-276 | Portugal |
| CHUC - Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra | 3000-075 | Portugal |
| ULSAM, EPE - Hospital Conde de Bertiandos | Ponte de Lima | 4990-041 | Portugal |
| Centro Hospitalar São João,EPE | Porto | 4200-319 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | 4434-502 | Portugal |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Dr. Peset | Valencia | 46017 | Spain |
| Hospital Politècnic La Fe | Valencia | 46026 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | 36312 | Spain |
| Clinical Rheumatology Research Center Sahlgrenska | Gothenburg | 413 45 | Sweden |
| Kantonspital St. Gallen, Rheumatologie Department | Sankt Gallen | 9007 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Songklanagarind Hospital | Hat Yai | 90110 | Thailand |
| Srinagarind Hospital | Muang | 40002 | Thailand |
| Ramathibodi Hospital | Ratchathewi | 10400 | Thailand |
| Glasgow Royal Infirmary | Glasgow | G4 0SF | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| 37357024 | Derived | Volkmann ER, McMahan ZH, Smith V, Jouneau S, Miede C, Alves M, Herrick AL; SENSCIS Trial Investigators. Risk of Malnutrition in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo-Controlled SENSCIS Trial. Arthritis Care Res (Hoboken). 2023 Dec;75(12):2501-2507. doi: 10.1002/acr.25176. Epub 2023 Aug 7. |
| 37294870 | Derived | Allanore Y, Khanna D, Smith V, Aringer M, Hoffmann-Vold AM, Kuwana M, Merkel PA, Stock C, Sambevski S, Denton CP; SENSCIS Trial Investigators. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology (Oxford). 2024 Mar 1;63(3):639-647. doi: 10.1093/rheumatology/kead280. |
| 36111858 | Derived | Denton CP, Goh NS, Humphries SM, Maher TM, Spiera R, Devaraj A, Ho L, Stock C, Erhardt E, Alves M, Wells AU. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. Rheumatology (Oxford). 2023 May 2;62(5):1870-1876. doi: 10.1093/rheumatology/keac535. |
| 35790961 | Derived | Maher TM, Bourdin A, Volkmann ER, Vettori S, Distler JHW, Alves M, Stock C, Distler O. Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects. Respir Res. 2022 Jul 5;23(1):178. doi: 10.1186/s12931-022-02095-6. |
| 35640959 | Derived | Kreuter M, Hoffmann-Vold AM, Matucci-Cerinic M, Saketkoo LA, Highland KB, Wilson H, Alves M, Erhardt E, Schoof N, Maher TM. Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). 2023 Feb 6;62(SI):SI43-SI53. doi: 10.1093/rheumatology/keac325. |
| 35150246 | Derived | Volkmann ER, Kreuter M, Hoffmann-Vold AM, Wijsenbeek M, Smith V, Khanna D, Denton CP, Wuyts WA, Miede C, Alves M, Sambevski S, Allanore Y. Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091. |
| 35012623 | Derived | Kreuter M, Del Galdo F, Miede C, Khanna D, Wuyts WA, Hummers LK, Alves M, Schoof N, Stock C, Allanore Y. Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis. Arthritis Res Ther. 2022 Jan 10;24(1):19. doi: 10.1186/s13075-021-02710-9. |
| 33412120 | Derived | Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1. |
| 33328257 | Derived | Roennow A, Sauve M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houyez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473. |
| 33223487 | Derived | Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19. |
| 33142016 | Derived | Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8. |
| 32243207 | Derived | Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23. |
| 31112379 | Derived | Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20. |
| 28664834 | Derived | Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29. |
Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. |
| Treated Patients |
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| COMPLETED |
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| NOT COMPLETED |
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Treated set (TS): The treated set consisted of patients who were randomised to a treatment group and received at least 1 dose of trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. |
| BG001 | Nintedanib | Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline pulmonary efficacy variables - Forced Vital Capacity (FVC) | Mean | Standard Deviation | mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks | Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate. | Treated Set | Posted | Mean | Standard Error | millilitre (mL)/year (yr) | up to week (wk) 52 after the start of administration |
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| Secondary | Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52 | This is the first key secondary endpoint. The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Treated Set | Posted | Least Squares Mean | Standard Error | unit on scale | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52. | This is the second key secondary endpoint. The Saint George's Respiratory Questionnaire measures the health status in patients with chronic airflow limitation. It consists of 2 parts that cover 3 domains: symptoms, activities, and impacts. The symptom domain relates to the effect, frequency and severity of respiratory symptoms. The activity domain relates to activities that cause or are limited by breathlessness. The impact domain evaluates a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. The scores of these domains range from 0 (no impairment) to 100 (worst possible). The calculated total score summarises the impact of the disease on overall health status. A high score corresponds to worse health. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Treated set | Posted | Least Squares Mean | Standard Error | unit on scale | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks | Annual rate of decline in FVC in percentage (%) predicted over 52 weeks. For this endpoint reported means represent the adjusted rate. | Treated set | Posted | Mean | Standard Error | % predicted/yr | up to 52 weeks after the start of administration |
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| Secondary | Absolute Change From Baseline in FVC in mL at Week 52 | Absolute change from baseline in FVC in mL at Week 52. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Treated Set | Posted | Least Squares Mean | Standard Error | mL | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Relative Change From Baseline [%] of mRSS at Week 52 | Relative change from baseline [%] of mRSS at Week 52. The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52). | Treated set | Posted | Least Squares Mean | Standard Error | percent change | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Time to Death | Time to event analysis of patients with death. The number of observed patients with death are reported. | Treated set | Posted | Count of Participants | Participants | From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks) |
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| Secondary | The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52 | The percentage (%) of responder based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52. This is a composite endpoint, based on the mRSS, FVC percent predicted, HAQ-DI, patient's global impression of overall health Visual Analogue Scale (VAS) and physician's global impression of patient's overall health VAS, as well as the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension. The CRISS index score represents a probability of improvement and ranges between 0 and 1. This is a 2 stage process to predict probability of improvement: Step 1 - absence of major organ progression (SRC etc.) - score "0" Step 2 - predicted probability of improvement - (score "0 - 1") | Treated set | Posted | Number | (%) of responder based on CRISS | Week 52 |
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| Secondary | Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52 | Absolute change from baseline in Carbon Monoxide Diffusion Capacity (DLco) in % predicted at Week 52. Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Treated set | Posted | Least Squares Mean | Standard Error | % predicted DLco | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52 | Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) at Week 52. It is calculated at a visit by counting the total number of fingertips with ulcers (i.e. number of fingers with presence of digital ulcer ticked "Yes") at the corresponding visit Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Treated set | Posted | Least Squares Mean | Standard Error | fingers | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 | Absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52. The HAQ-DI score is calculated as follows: Each question is scored 0-3 (where 0= "without difficulty" & 3= "unable to do"). There are 8 categories (Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities), each including 2 or 3 questions. The score for each category corresponds to maximum question score within each category. Finally, HAQ-DI score corresponds to sum of the sub-scores of all 8 categories divided by number of categories completed. Please note that if there are fewer than 6 categories with responses, then a score cannot be calculated. The HAQ-DI score scale has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). A high score corresponds to worse impairment. Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Treated set | Posted | Least Squares Mean | Standard Error | unit on a scale | Baseline and up to 52 weeks after the start of administration |
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| Secondary | Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52 | Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) dyspnoea score at Week 52. FACIT-Dyspnoea (Dyspnoea) 10 Item Short Form include a 4-point rating scale (no shortness of breath=0; mildly short of breath=1; moderately short of breath = 2; severely short of breath =3; or I did not do this in the past 7 days =4). A raw score is calculated as: Sum individual item scores * 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. FACIT dyspnea scale score ranges between 0 and 75.9. The FACIT-Dyspnea short forms are scored such that a high score represents high levels of dyspnea. Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52). | Treated set | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline and up to 52 weeks after the start of administration |
|
From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. | 9 | 288 | 79 | 288 | 239 | 288 |
| EG001 | Nintedanib | Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. | 10 | 288 | 88 | 288 | 270 | 288 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
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| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Pleuropericarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 21.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Retinal vein occlusion | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Intestinal mass | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Brain death | General disorders | MedDRA 21.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Polyp | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Hepatocellular injury | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
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| Adenovirus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Campylobacter gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Cell marker increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Forced vital capacity decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drooping shoulder syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Systemic scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Benign mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Sweat gland tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cerebral amyloid angiopathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cerebral microhaemorrhage | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Scleroderma renal crisis | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vulvovaginal swelling | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Systemic sclerosis pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Digital pitting scar | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sclerema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2018 | Oct 28, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
| This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC [mL]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status & gender, fixed continuous effects of time & bl. FVC (mL), age, height, trt -by time & bl.-by-time interactions. Random effects included for patient response for both time & intercept. Within-patient errors were modelled by an Unstructured variance-covariance matrix. | random coefficient regression | The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial. | 0.0378 | Mean Difference (Final Values) | 43.13 | 2-Sided | 95 | 2.44 | 83.83 | Other |
| In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA. | random coefficient regression | 0.1046 | Mean Difference (Final Values) | 30.00 | 2-Sided | 95 | -6.22 | 66.22 | Other |
| In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA | random coefficient regression | 0.0740 | Mean Difference (Final Values) | 32.93 | 2-Sided | 95 | -3.19 | 69.06 | Other |
| In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA. | random coefficient regression | 0.0644 | Mean Difference (Final Values) | 33.86 | 2-Sided | 95 | -2.03 | 69.75 | Other |
| This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept. | random coefficient regression | 0.0351 | Mean Difference (Final Values) | 40.95 | 2-Sided | 95 | 2.88 | 79.01 | Other |
| This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept | random coefficient regression | 0.0349 | Mean Difference (Final Values) | 40.98 | 2-Sided | 95 | 2.92 | 79.04 | Other |
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Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
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Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
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