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The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: Dose Level 1 | Experimental | Subjects receive daily dose of 420 mg of Ibrutinib capsules |
|
| Phase 1b: Dose Level 2 | Experimental | Subjects receive daily dose of 280 mg of Ibrutinib capsules |
|
| Phase 1b: Dose Level 3 | Experimental | Subjects receive daily dose of 140 mg of Ibrutinib capsules |
|
| Phase 2 | Experimental | Subjects receive daily dose of recommended phase 2 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. | Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib | 28 treatment days after last subject enrolled in Phase 1 dose level(s). |
| Phase 2: Overall Response Rate as the Percentage of Participants With Response | Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site). | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Response Rate as the Percentage of Participants With Sustained Response | For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable. | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lori Styles, MD | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34102349 | Derived | Doki N, Toyosaki M, Shiratori S, Osumi T, Okada M, Kawakita T, Sawa M, Ishikawa T, Ueda Y, Yoshinari N, Nakahara S. An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease. Transplant Cell Ther. 2021 Oct;27(10):867.e1-867.e9. doi: 10.1016/j.jtct.2021.05.019. Epub 2021 Jun 6. | |
| 31260802 |
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b/Phase 2 | Subjects receive daily dose of 420 mg of Ibrutinib capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 21, 2015 | Apr 30, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR) | For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable. | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
| Corticosteroid Requirement Changes Over Time | Average daily corticosteroid dose assessed each week. | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
| Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score | Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in >7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life. 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. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome. | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
| Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib | From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Stanford University | Stanford | California | 94305 | United States |
| Emory University, Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Vanderbilt University Medical Center, Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Waller EK, Miklos D, Cutler C, Arora M, Jagasia MH, Pusic I, Flowers MED, Logan AC, Nakamura R, Chang S, Clow F, Lal ID, Styles L, Jaglowski S. Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study. Biol Blood Marrow Transplant. 2019 Oct;25(10):2002-2007. doi: 10.1016/j.bbmt.2019.06.023. Epub 2019 Jun 28. |
| 28924018 | Derived | Miklos D, Cutler CS, Arora M, Waller EK, Jagasia M, Pusic I, Flowers ME, Logan AC, Nakamura R, Blazar BR, Li Y, Chang S, Lal I, Dubovsky J, James DF, Styles L, Jaglowski S. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017 Nov 23;130(21):2243-2250. doi: 10.1182/blood-2017-07-793786. Epub 2017 Sep 18. |
| All-Treated Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline analysis population includes all participants that received at least 1 dose of ibrutinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b/Phase 2 | Subjects receive daily dose of 420 mg of Ibrutinib capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. | Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib | Endpoint only includes Phase 1 data. | Posted | Count of Participants | Participants | 28 treatment days after last subject enrolled in Phase 1 dose level(s). |
|
|
| |||||||||||||||||||||||||||||
| Primary | Phase 2: Overall Response Rate as the Percentage of Participants With Response | Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site). | Efficacy analyses were performed using the All-treated Population (N = 42) | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Sustained Response Rate as the Percentage of Participants With Sustained Response | For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable. | Phase 2 subjects include all subjects who participated in phase 1b. Subjects evaluated for sustained response includes participants who had achieved an NIH-defined CR or PR. | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR) | For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable. | Phase 2 subjects includes all subjects who participated in Phase 1b | Posted | Median | 95% Confidence Interval | Median | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Corticosteroid Requirement Changes Over Time | Average daily corticosteroid dose assessed each week. | Phase 2 subjects includes all subjects who participated in Phase 1b. | Posted | Median | Full Range | Daily Dose of Steroid by Weight (mg/kg/d | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score | Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in >7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life. 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. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome. | All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose. | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib | Phase 2 subjects includes all subjects who participated in Phase 1b | Posted | Count of Participants | Participants | From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months |
|
|
From first dose of study drug to within 30 days of last dose or starting subsequent therapy for cGVHD, up to 36.7 months
Adverse events were not collected by phase because the phase 1 part of the study confirmed the first dose level (420mg was acceptable for cGVHD subjects and it was used as the recommended Phase 2 dose (RP2D). The Safety Population was the same as the All-treated Population (ie, all subject who received at least 1 dose of ibrutinib at the RP2D)
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 | Phase1b/Phase 2 | Subjects receive daily dose of 420 mg of Ibrutinib capsules | 7 | 42 | 22 | 42 | 41 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial fibrilation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Prolymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac Disorders | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroesophogeal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatique | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infections | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neoplasms benign, malignant unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Psychiatric disorders | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Delerium | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
Institution/Investigator will not publish without Sponsor prior review and approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manuela Juretic, Associate Director, Clinical Operations | Pharmacyclics LLC, An AbbVie Company | (408) 215.3628 | mjuretic@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2016 | Apr 30, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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