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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib + Prednisone | Experimental | Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for cytochrome P450 [CYP] inhibitors or hepatic dysfunction as applicable. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
| Placebo + Prednisone | Placebo Comparator | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibrutinib | Drug | Ibrutinib capsules administered orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis: Response Rate at 48 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | 48 weeks (Cumulatively up to 30 March 2020) |
| Final Analysis: Response Rate at 48 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | 48 weeks (Cumulatively up to 12 July 2021) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Wahlstrom, MD | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120 | Scottsdale | Arizona | 85258-4547 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36608310 | Derived | Miklos DB, Abu Zaid M, Cooney JP, Albring JC, Flowers M, Skarbnik AP, Yakoub-Agha I, Ko BS, Bruno B, Waller EK, Yared J, Sohn SK, Bulabois CE, Teshima T, Jacobsohn D, Greinix H, Mokatrin A, Lee Y, Wahlstrom JT, Styles L, Socie G. Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study. J Clin Oncol. 2023 Apr 1;41(10):1876-1887. doi: 10.1200/JCO.22.00509. Epub 2023 Jan 6. |
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Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.
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Participants were enrolled at 66 sites overall: 24 sites in North America, and 42 sites in the rest of the world.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrutinib + Prednisone | Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for cytochrome P450 [CYP] inhibitors or hepatic dysfunction as applicable. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
| 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 6, 2019 | Mar 11, 2021 |
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| Placebo | Drug | Placebo capsules administered orally daily |
|
| Prednisone | Drug | Prednisone administered daily |
|
| Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020) |
| Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) |
| Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. | Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020) |
| Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) |
| Primary Analysis: Response Rate at 24 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | 24 weeks (Cumulatively up to 30 March 2020) |
| Final Analysis: Response Rate at 24 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | 24 weeks (Cumulatively up to 12 July 2021) |
| Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment. The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020) |
| Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment. The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021) |
| Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days | 24 weeks (Cumulatively up to 30 March 2020) |
| Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days | 24 weeks (Cumulatively up to 12 July 2021) |
| Primary Analysis: Overall Survival (OS) | OS was defined as the time of randomization until the time of death due to any cause, in months. | Median time on study (cumulatively up to 30 March 2020) was 19.8 months and 18.4 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively. |
| Final Analysis: OS | OS was defined as the time of randomization until the time of death due to any cause, in months. | Median time on study (cumulatively up to 12 July 2021) was 33.1 months and 32.5 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively. |
| Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time | Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. | Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020) |
| Final Analysis: DOR for Participants Who Had PR or CR at Any Time | Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. | Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021) |
| Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone | AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. | From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 30 March 2020), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months. |
| Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone | AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. | From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 12 July 2021), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months. |
| LPCH Stanford /ID# 1140-1128 |
| Palo Alto |
| California |
| 94304 |
| United States |
| Ucsf /Id# 1140-0003 | San Francisco | California | 94143 | United States |
| Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400 | Stanford | California | 94305 | United States |
| UCHSC Anschultz Cancer Pavilion /ID# 1140-0068 | Aurora | Colorado | 80010 | United States |
| Children's National Medical Center /ID# 1140-1122 | Washington D.C. | District of Columbia | 20010 | United States |
| Jackson Memorial Hospital, University of Miami /ID# 1140-0647 | Miami | Florida | 33136-1096 | United States |
| Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121 | Orlando | Florida | 32804 | United States |
| Emory University, Winship Cancer Institute /ID# 1140-0033 | Atlanta | Georgia | 30322 | United States |
| Emory University/Winship Cancer Institute /ID# 1140-1179 | Atlanta | Georgia | 30322 | United States |
| University of Chicago /ID# 1140-0126 | Chicago | Illinois | 60637 | United States |
| Loyola University /ID# 1140-0713 | Maywood | Illinois | 60153 | United States |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010 | Indianapolis | Indiana | 46202-5112 | United States |
| University of Kentucky /ID# 1140-1140 | Lexington | Kentucky | 40508-2678 | United States |
| University of Louisville Hospital /ID# 1140-1131 | Louisville | Kentucky | 40202 | United States |
| University of Maryland /ID# 1140-0205 | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital Cancer Center /ID# 1140-0020 | Boston | Massachusetts | 02114 | United States |
| Boston Childrens Hospital /ID# 1140-1615 | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute /ID# 1140-0349 | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer In /ID# 1140-0130 | Detroit | Michigan | 48201 | United States |
| University of Minnesota /ID# 1140-0807 | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic, Rochester, MN /ID# 1140-0240 | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343 | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of NJ /ID# 1140-0803 | New Brunswick | New Jersey | 08903 | United States |
| New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200 | New York | New York | 10021 | United States |
| Stony Brook University Medical Center /ID# 1140-0719 | New York | New York | 10021 | United States |
| Columbia University Medical Center, MS-CHONY /ID# 1140-1124 | New York | New York | 10032-1559 | United States |
| Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019 | New York | New York | 10065 | United States |
| University of Rochester Cancer Center /ID# 1140-0127 | Rochester | New York | 14642-0001 | United States |
| Montefiore Medical Center - Moses Campus /ID# 1140-0120 | The Bronx | New York | 10467 | United States |
| University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133 | Chapel Hill | North Carolina | 27516 | United States |
| Univ Hosp Cleveland /ID# 1140-0941 | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050 | Pittsburgh | Pennsylvania | 15232 | United States |
| Medical University of South Carolina, MUSC /ID# 1140-0738 | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024 | Nashville | Tennessee | 37232-5280 | United States |
| Methodist San Antonio /ID# 1140-1118 | San Antonio | Texas | 78229-3710 | United States |
| Fred Hutchinson Cancer Research Center /ID# 1140-0404 | Seattle | Washington | 98109 | United States |
| West Virginia University /ID# 1140-1090 | Morgantown | West Virginia | 26506 | United States |
| The Kinghorn Cancer Centre /ID# 1140-1165 | Darlinghurst | New South Wales | 2010 | Australia |
| Westmead Hospital /ID# 1140-0848 | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital /ID# 1140-0190 | Herston | Queensland | 4029 | Australia |
| Royal Children's Hospital/ID# 1140-1154 | Parkville | Victoria | 3052 | Australia |
| Royal Melbourne Hospital (RMH) /ID# 1140-0633 | Parkville | Victoria | 3052 | Australia |
| Fiona Stanley Hospital /ID# 1140-0880 | Perth | Western Australia | 6000 | Australia |
| Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373 | Graz | 8036 | Austria |
| Krankenhaus der Elisabethinen Linz /ID# 1140-0849 | Linz | 4020 | Austria |
| University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166 | Vancouver | British Columbia | V5Z 1M9 | Canada |
| The Ottawa Hospital Regional Cancer Center /ID# 1140-0159 | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre /ID# 1140-0043 | Toronto | Ontario | M5G 2M9 | Canada |
| CHU Sainte-Justine /ID# 1140-1143 | Montreal | Quebec | H3T 1C5 | Canada |
| The First Affiliated Hospital of Soochow University /ID# 1140-1208 | Suzhou | Jiangsu | 215006 | China |
| Chinese PLA General Hospital /ID# 1140-1198 | Beijing | 100853 | China |
| Nanfang Hospital /ID# 1140-1379 | Guangzhou | 510000 | China |
| UHC Zagreb /ID# 1140-1169 | Zagreb | 10000 | Croatia |
| Hopital de Brabois /ID# 1140-0775 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| CHU Amiens Groupe hospitalier Sud /ID# 1140-1205 | Amiens | 80054 | France |
| CHU de GRENOBLE Alpes /ID# 1140-1058 | Grenoble | 38043 | France |
| Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750 | Lille | 59037 | France |
| CHU de Nantes /ID# 1140-0520 | Nantes | 44093 | France |
| Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918 | Paris | 33000 | France |
| Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735 | Paris | Île-de-France Region | 75010 | France |
| Robert Bosch Hospital /ID# 1140-1160 | Stuttgart | Baden-Wurttemberg | 70376 | Germany |
| Universitatsklinikum Munster /ID# 1140-1195 | Munster | Lower Saxony | 48149 | Germany |
| Universitaetsklinikum Dresden /ID# 1140-1367 | Dresden | 01307 | Germany |
| Hannover Medical School /ID# 1140-1141 | Hanover | 30625 | Germany |
| Dr. Haunerschen Kinderspital /ID# 1140-1142 | Munich | 80337 | Germany |
| University Hospital of Regensburg /ID# 1140-1446 | Regensburg | 93053 | Germany |
| St. Laszlo Hospital /ID# 1140-1164 | Budapest | 1097 | Hungary |
| IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150 | Rome | Lazio | 00165 | Italy |
| A.O. Univ. Ospedali Riuniti /ID# 1140-0932 | Ancona | The Marches | 60126 | Italy |
| ASST Papa Giovanni XXIII /ID# 1140-1231 | Bergamo | 24127 | Italy |
| Ospedale San Raffaele IRCCS /ID# 1140-0523 | Milan | 20132 | Italy |
| University of Torino /ID# 1140-1268 | Torino | 10124 | Italy |
| Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156 | Turin | 10126 | Italy |
| Anjou Kousei Hospital /ID# 1140-1435 | Anjo | Aichi-ken | 446-8602 | Japan |
| Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437 | Hiroshima | Hiroshima | 730-8619 | Japan |
| Kobe City Medical Center General Hospital /ID# 1140-1438 | Kobe | Hyōgo | 650-0047 | Japan |
| Hyogo College of Medicine College Hospital /Id# 1140-1434 | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| Duplicate_University of Tsukuba Hospital /ID# 1140-1445 | Tsukuba | Ibaraki | 305-8576 | Japan |
| Tokai University Hospital /ID# 1140-1444 | Isehara-shi | Kanagawa | 259-1193 | Japan |
| Duplicate_Kurashiki Central Hospital /ID# 1140-1442 | Kurishiki-shi | Okayama-ken | 710-8602 | Japan |
| Okayama University Hospital /ID# 1140-1430 | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka Women's and Children's Hospital /ID# 1140-1440 | Izumi-Shi | Osaka | 594-1101 | Japan |
| Osaka City University Hospital /ID# 1140-1157 | Osaka | Osaka | 545-8586 | Japan |
| Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439 | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| National Center for Child Health and Development /ID# 1140-1443 | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Kumamoto Medical Center /ID# 1140-1431 | Kumamoto | 860-0008 | Japan |
| Hokkaido University Hospital /ID# 1140-1436 | Sapporo | 060-8648 | Japan |
| National University Cancer Institute - National University Health System /ID# 1140-1155 | Singapore | 119228 | Singapore |
| Singapore General Hospital /ID# 1140-1162 | Singapore | 169608 | Singapore |
| Kyungpook National Univ Hosp /ID# 1140-1153 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Yonsei University Health System, Severance Hospital /ID# 1140-0927 | Seodaemun-gu | Seoul Teugbyeolsi | 03722 | South Korea |
| Samsung Medical Center /ID# 1140-0925 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Cath Univ Seoul St Mary's Hosp /ID# 1140-0928 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| SoonChunHyang University Seoul /ID# 1140-1163 | Seoul | 04401 | South Korea |
| Asan Medical Center /ID# 1140-0963 | Seoul | 05505 | South Korea |
| Hospital Clinic /ID# 1140-0533 | Barcelona | 08036 | Spain |
| Hospital Santa Creu i Sant Pau /ID# 1140-0535 | Barcelona | 08041 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 1140-0863 | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia /ID# 1140-1145 | Valencia | 46010 | Spain |
| China Medical University Hosp /ID# 1140-1199 | Taichung | Taichung | 40447 | Taiwan |
| National Taiwan Univ Hosp /ID# 1140-1184 | Taipei City | Taipei | 10002 | Taiwan |
| FG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibrutinib + Prednisone | Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for CYP inhibitors or hepatic dysfunction as applicable. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
| BG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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 | Primary Analysis: Response Rate at 48 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | 48 weeks (Cumulatively up to 30 March 2020) |
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| Primary | Final Analysis: Response Rate at 48 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | 48 weeks (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. | Intent to Treat Population: all randomized participants. Participants with withdrawal of all corticosteroids. No participants were on corticosteroids at 21 and 24 Months in the Ibrutinib + Prednisone Arm/Group. | Posted | Number | 95% Confidence Interval | proportion of participants | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020) |
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| Secondary | Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD | The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. | Intent to Treat Population: all randomized participants. Participants with withdrawal of all corticosteroids. No participants were on corticosteroids at 21 and 24 Months in the Ibrutinib + Prednisone Arm/Group. | Posted | Number | 95% Confidence Interval | proportion of participants | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. | Intent to Treat Population: all randomized participants. Participants with withdrawal of all immunosuppressants | Posted | Number | 95% Confidence Interval | proportion of participants | Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020) |
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| Secondary | Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants | The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. | Intent to Treat Population: all randomized participants. Participants with withdrawal of all immunosuppressants | Posted | Number | 95% Confidence Interval | proportion of participants | Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Response Rate at 24 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | 24 weeks (Cumulatively up to 30 March 2020) |
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| Secondary | Final Analysis: Response Rate at 24 Weeks | Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks. Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | 24 weeks (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment. The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020) |
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| Secondary | Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits | Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment. The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | 24 weeks (Cumulatively up to 30 March 2020) |
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| Secondary | Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days | Intent to Treat Population: all randomized participants. | Posted | Number | percentage of participants | 24 weeks (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Overall Survival (OS) | OS was defined as the time of randomization until the time of death due to any cause, in months. | Intent to Treat Population: all randomized participants. | Posted | Median | 95% Confidence Interval | months | Median time on study (cumulatively up to 30 March 2020) was 19.8 months and 18.4 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively. |
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| Secondary | Final Analysis: OS | OS was defined as the time of randomization until the time of death due to any cause, in months. | Intent to Treat Population: all randomized participants. | Posted | Median | 95% Confidence Interval | months | Median time on study (cumulatively up to 12 July 2021) was 33.1 months and 32.5 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively. |
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| Secondary | Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time | Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. | Participants in the Intent-to-Treat Population (all randomized participants) who had response of CR/PR at any time during the study and had not started any subsequent therapy for cGVHD or had evidence of relapse of their underlying disease that was indication for transplant at the time of response. | Posted | Median | 95% Confidence Interval | months | Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020) |
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| Secondary | Final Analysis: DOR for Participants Who Had PR or CR at Any Time | Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. | Participants in the Intent-to-Treat Population (all randomized participants) who had response of CR/PR at any time during the study and had not started any subsequent therapy for cGVHD or had evidence of relapse of their underlying disease that was indication for transplant at the time of response. | Posted | Median | 95% Confidence Interval | months | Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021) |
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| Secondary | Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone | AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. | Safety Population: all participants who received at least one dose of either ibrutinib or placebo, analyzed according to the actual treatment received. | Posted | Count of Participants | Participants | No | From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 30 March 2020), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months. |
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| Secondary | Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone | AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. | Safety Population: all participants who received at least one dose of either ibrutinib or placebo, analyzed according to the actual treatment received. | Posted | Count of Participants | Participants | No | From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 12 July 2021), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months. |
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From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 12 July 2021), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrutinib | Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for cytochrome P450 [CYP] inhibitors or hepatic dysfunction as applicable. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. | 23 | 94 | 51 | 94 | 88 | 94 |
| EG001 | Placebo | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. | 22 | 96 | 49 | 96 | 92 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| MYOCARDITIS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| DIPLOPIA | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| ILEUS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| PANCREATIC ENZYME ABNORMALITY | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 24.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 24.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 24.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| GRAFT VERSUS HOST DISEASE | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| CHRONIC GRAFT VERSUS HOST DISEASE | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| BACTERAEMIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| CYTOMEGALOVIRUS COLITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| CYTOMEGALOVIRUS INFECTION REACTIVATION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| DACRYOCYSTITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| ENCEPHALITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| EPSTEIN-BARR VIRUS INFECTION REACTIVATION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| EYE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| HAEMOPHILUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| KLEBSIELLA BACTERAEMIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| KLEBSIELLA SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| MASTOIDITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| MEDIASTINITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| METAPNEUMOVIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PARAINFLUENZAE VIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PAROTITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PERIORBITAL CELLULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PERITONITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA CYTOMEGALOVIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA LEGIONELLA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA PARAINFLUENZAE VIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA VIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| SINUSITIS FUNGAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| URINARY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| WOUND INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
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| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| STEROID DIABETES | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| MUSCLE ATROPHY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| MYOPATHY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE PROMYELOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BENIGN NEOPLASM OF TESTIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LEUKAEMIA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PRIMARY MYELOFIBROSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUBSTANCE-INDUCED PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CYSTITIS HAEMORRHAGIC | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OBSTRUCTIVE NEPHROPATHY | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| URETHRAL STENOSIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTERMENSTRUAL BLEEDING | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SCROTAL OEDEMA | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CUSHINGOID | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RHINOVIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin Wahlstrom MD | Pharmacyclics, LLC | 669-215-7210 | jwahlstrom@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2020 | Mar 11, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 |
| Placebo + Prednisone |
Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 |
| Placebo + Prednisone |
Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 |
| Placebo + Prednisone |
Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 |
| Placebo + Prednisone |
Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|
| OG001 | Placebo + Prednisone | Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses. |
|
|