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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060GVH3001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib | Experimental | Participants will receive 420 milligram (mg) oral ibrutinib once daily starting on Week 1 Day 1, unless they have intervening unacceptable toxicity or meet other criteria for participants discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Participants will receive 420 mg (3 * 140 mg capsules) oral ibrutinib once daily starting on Week 1 Day 1, unless they have intervening unacceptable toxicity or meet other criteria for participants discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) in the absence of new therapy for chronic graft versus host disease (cGVHD) and absence of progression of underlying disease or death based on the National Institutes of Health (NIH) Consensus Development Project Criteria (2014). 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; and chronic graft versus host disease (cGVHD) progression is defined as clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. | Up to 3 year 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Response Rate | Sustained response rate was defined as percentage of participants with NIH defined CR or PR that was sustained for at least 20 weeks. 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. | Up to 3 year 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo Kosei Hospital | Anjo-shi | 446-8602 | Japan | |||
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38149026 | Derived | Toyosaki M, Doki N, Shiratori S, Osumi T, Okada M, Kawakita T, Sawa M, Ishikawa T, Ueda Y, Hatayama T, Yoshinari N, Fujikawa E. Long-term Use of Ibrutinib in Japanese Patients with Steroid Dependent/Refractory cGVHD: Final Analysis of Multicenter Study. Blood Cell Ther. 2023 Nov 10;6(4):104-113. doi: 10.31547/bct-2023-010. eCollection 2023 Nov 25. | |
| 34102349 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrutinib 420 mg | Participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) received ibrutinib 420 milligrams (mg) (3*140 mg capsule) orally once daily on Week 1 Day 1 until participants had intervening unacceptable toxicity or met other criteria for discontinuation. |
| 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 | Jul 24, 2018 | Nov 27, 2022 |
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|
| Duration of Response (DOR) | DOR is defined as the duration from the date of initial response (CR or PR) to the date of progressive cGVHD or death, whichever occurred first. 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; and cGVHD progression is defined as clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. | Up to 3 year 6 months |
| cGVHD Response Rate at Each Timepoints | cGVHD response rate was defined as percentage of participants with NIH defined CR or PR at each timepoint. 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. | Weeks 5, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157 |
| Change in the Amount of Corticosteroid Required Over Time | Change in the amount of corticosteroid required over time was reported. | Baseline, Weeks 24, 48, 96, and 144 |
| Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Scale Score | Percentage of participants with overall improvement in Lee cGVHD symptom scale score was reported. Lee cGVHD symptom scale is a patient-reported symptom scale used to measure symptom burden and 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 was 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 with a higher score indicating worse symptoms. An overall score was calculated as the average of these 7 subscales if at least 4 subscales had valid scores. A change of greater than or equal to (>=) 7 points on the Lee cGVHD symptom scale overall score was considered significant and relates to improvement in quality of life (QoL). | Up to 3 year 6 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are adverse events with onset during the treatment phase or that were a consequence of a preexisting condition that has worsened since baseline, and occurred during treatment or within 30 days following the last dose of study treatment, or any adverse event that was considered study treatment-related regardless of the start date of the event. | Up to 3 year 6 months |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of Ibrutinib | AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC [0-24]) of Ibrutinib | AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of ibrutinib. | 0 to 24 hours (Day 1 of Weeks 1 and 2) |
| Maximum Observed Plasma Concentration (Cmax) of Ibrutinib | Cmax is defined as maximum observed plasma concentration of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibrutinib | Tmax is defined as time to reach the maximum observed plasma concentration of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Elimination Half-Life (t1/2) of Ibrutinib | T1/2 is defined as elimination half-life of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Apparent Clearance (CL/F) of Ibrutinib | CL/F is defined as apparent clearance of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Apparent Volume of Distribution (Vd/F) of Ibrutinib | Vd/F is defined as apparent volume of distribution of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ibrutinib | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of ibrutinib. | Day 1 of Weeks 1 and 2 |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of PCI-45227 | AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of PCI-45227 | AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of PCI-45227. | 0 to 24 hours (Day 1 of Weeks 1 and 2) |
| Maximum Observed Plasma Concentration (Cmax) of PCI-45227 | Cmax is defined as maximum observed plasma concentration of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PCI-45227 | Tmax is defined as time to reach the maximum observed plasma concentration of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Elimination Half-Life (t1/2) of PCI-45227 | T1/2 is defined as elimination half-life of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Apparent Clearance (CL/F) of PCI-45227 | CL/F is defined as apparent clearance of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Apparent Volume of Distribution (Vd/F) of PCI-45227 | Vd/F is defined as apparent volume of distribution of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of PCI-45227 | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of PCI-45227. | Day 1 of Weeks 1 and 2 |
| Bunkyō City |
| 113 8677 |
| Japan |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima | 730-8619 | Japan |
| Tokai University Hospital | Isehara | 259-1193 | Japan |
| Osaka Women's and Children's Hospital | Izumi | 594-1101 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650 0047 | Japan |
| National Hospital Organization Kumamoto Medical Center | Kumamoto | 860-0008 | Japan |
| Kurashiki Central Hospital | Kurashiki | 710-8602 | Japan |
| Gunmaken Saiseikai Maebashi Hospital | Maebashi | 371-0821 | Japan |
| Japanese Red Cross Nagoya Daiichi Hospital | Nagoya | 453-8511 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | 663-8501 | Japan |
| Okayama University Hospital | Okayama | 700 8558 | Japan |
| Osaka City University Hospital | Osaka | 545 8586 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| National Center for Child Health and Development | Setagaya Ku | 157 8535 | Japan |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibrutinib 420 mg | Participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) received ibrutinib 420 milligrams (mg) (3*140 mg capsule) orally once daily on Week 1 Day 1 until participants had intervening unacceptable toxicity or met other criteria for discontinuation. |
| 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 |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) in the absence of new therapy for chronic graft versus host disease (cGVHD) and absence of progression of underlying disease or death based on the National Institutes of Health (NIH) Consensus Development Project Criteria (2014). 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; and chronic graft versus host disease (cGVHD) progression is defined as clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 3 year 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Sustained Response Rate | Sustained response rate was defined as percentage of participants with NIH defined CR or PR that was sustained for at least 20 weeks. 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. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug and achieved PR or better response. | Posted | Number | Percentage of participants | Up to 3 year 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the duration from the date of initial response (CR or PR) to the date of progressive cGVHD or death, whichever occurred first. 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; and cGVHD progression is defined as clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug and achieved PR or better response. | Posted | Median | 95% Confidence Interval | Months | Up to 3 year 6 months |
|
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| Secondary | cGVHD Response Rate at Each Timepoints | cGVHD response rate was defined as percentage of participants with NIH defined CR or PR at each timepoint. 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. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Weeks 5, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157 |
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| Secondary | Change in the Amount of Corticosteroid Required Over Time | Change in the amount of corticosteroid required over time was reported. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' (number analyzed) represents number of participants evaluable at the specified timepoints. | Posted | Median | Full Range | Milligrams per kilograms per day | Baseline, Weeks 24, 48, 96, and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Scale Score | Percentage of participants with overall improvement in Lee cGVHD symptom scale score was reported. Lee cGVHD symptom scale is a patient-reported symptom scale used to measure symptom burden and 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 was 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 with a higher score indicating worse symptoms. An overall score was calculated as the average of these 7 subscales if at least 4 subscales had valid scores. A change of greater than or equal to (>=) 7 points on the Lee cGVHD symptom scale overall score was considered significant and relates to improvement in quality of life (QoL). | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 year 6 months |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are adverse events with onset during the treatment phase or that were a consequence of a preexisting condition that has worsened since baseline, and occurred during treatment or within 30 days following the last dose of study treatment, or any adverse event that was considered study treatment-related regardless of the start date of the event. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 3 year 6 months |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of Ibrutinib | AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of ibrutinib. | The pharmacokinetic (PK) evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. | Posted | Mean | Standard Deviation | hours*nanograms per milliliter (h*ng/mL) | Day 1 of Weeks 1 and 2 |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC [0-24]) of Ibrutinib | AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of ibrutinib. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | hour*ng/mL | 0 to 24 hours (Day 1 of Weeks 1 and 2) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ibrutinib | Cmax is defined as maximum observed plasma concentration of ibrutinib. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | Day 1 of Weeks 1 and 2 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibrutinib | Tmax is defined as time to reach the maximum observed plasma concentration of ibrutinib. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. | Posted | Median | Full Range | Hours | Day 1 of Weeks 1 and 2 |
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| Secondary | Elimination Half-Life (t1/2) of Ibrutinib | T1/2 is defined as elimination half-life of ibrutinib. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Hours | Day 1 of Weeks 1 and 2 |
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| Secondary | Apparent Clearance (CL/F) of Ibrutinib | CL/F is defined as apparent clearance of ibrutinib. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Milliliters per hour (mL/h) | Day 1 of Weeks 1 and 2 |
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| Secondary | Apparent Volume of Distribution (Vd/F) of Ibrutinib | Vd/F is defined as apparent volume of distribution of ibrutinib. | The PK evaluable analysis set included enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | Milliliters (mL) | Day 1 of Weeks 1 and 2 |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ibrutinib | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of ibrutinib. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hour*ng/mL | Day 1 of Weeks 1 and 2 |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of PCI-45227 | AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 of Weeks 1 and 2 |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of PCI-45227 | AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | hour*ng/mL | 0 to 24 hours (Day 1 of Weeks 1 and 2) |
|
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PCI-45227 | Cmax is defined as maximum observed plasma concentration of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. | Posted | Mean | Standard Deviation | ng/mL | Day 1 of Weeks 1 and 2 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PCI-45227 | Tmax is defined as time to reach the maximum observed plasma concentration of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. | Posted | Median | Full Range | Hours | Day 1 of Weeks 1 and 2 |
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| Secondary | Elimination Half-Life (t1/2) of PCI-45227 | T1/2 is defined as elimination half-life of PCI-45227. | The PK evaluable analysis set is defined as all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Median | Full Range | Hours | Day 1 of Weeks 1 and 2 |
|
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| Secondary | Apparent Clearance (CL/F) of PCI-45227 | CL/F is defined as apparent clearance of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | mL/h | Day 1 of Weeks 1 and 2 |
|
| ||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vd/F) of PCI-45227 | Vd/F is defined as apparent volume of distribution of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | mL | Day 1 of Weeks 1 and 2 |
|
| ||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of PCI-45227 | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of PCI-45227. | The PK evaluable analysis set included all enrolled participants who received at least one dose of study drug and had at least 1 postdose PK sample obtained. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | hour*ng/mL | Day 1 of Weeks 1 and 2 |
|
|
Up to 3 year 6 months
The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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 | Ibrutinib 420 mg | Participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) received ibrutinib 420 milligrams (mg) (3*140 mg capsule) orally once daily on Week 1 Day 1 until participants had intervening unacceptable toxicity or met other criteria for discontinuation. | 7 | 19 | 12 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Liver Disorder | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Appendiceal Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Fungal | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atypical Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Increased Tendency to Bruise | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Splenic Infarction | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure Chronic | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Conjunctival Erosion | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Conjunctival Hyperaemia | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ocular Hypertension | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastric Mucosal Hypertrophy | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Tooth Loss | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Physical Deconditioning | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Liver Disorder | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Appendiceal Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematoma Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Fungal | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pseudomembranous Colitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atypical Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bone Contusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Traumatic Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Aspergillus Test Positive | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Beta-D-Glucan Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Fibrinogen Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lipid Metabolism Disorder | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Zinc Deficiency | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Immobilisation Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteonecrosis of Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acute Lymphocytic Leukaemia Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyogenic Granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Intercostal Neuralgia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Restless Legs Syndrome | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Toxic Encephalopathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemorrhage Subcutaneous | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ingrowing Nail | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Atrophy | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Induration | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Toxic Skin Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EXECUTIVE MEDICAL DIRECTOR | Janssen Pharmaceutical K.K. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2022 | Nov 27, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System 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 |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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