## Protocol Section
### Identification Module
**NCT ID:** NCT03474679

**Brief Title:** A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)

**Official Title:** A Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)

#### Organization Study ID Info
**ID:** CR108443
#### Organization
**Class:** INDUSTRY
**Full Name:** Janssen Pharmaceutical K.K.
#### Secondary ID Infos
**Domain:** Janssen Pharmaceutical K.K., Japan
**ID:** 54179060GVH3001
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2021-11-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-11-29

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-02-03

**Type:** ACTUAL

**Results First Submit Date:** 2022-11-27

**Results First Submit QC Date:** 2023-01-17

#### Start Date
**Date:** 2018-05-01

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2018-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-16
**Study First Submit QC Date:** 2018-03-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Janssen Pharmaceutical K.K.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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 \[2014\]).

### Conditions Module

**Conditions:**

- Graft vs Host Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 19

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Ibrutinib

**Label:** Ibrutinib

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ibrutinib

**Description:** 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.

**Name:** Ibrutinib

**Other Names:**

- PCI-32765

- JNJ-54179060

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Overall Response Rate (ORR)

**Time Frame:** Up to 3 year 6 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Sustained Response Rate

**Time Frame:** Up to 3 year 6 months

**Description:** 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.

**Measure:** Duration of Response (DOR)

**Time Frame:** Up to 3 year 6 months

**Description:** 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.

**Measure:** cGVHD Response Rate at Each Timepoints

**Time Frame:** Weeks 5, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157

**Description:** Change in the amount of corticosteroid required over time was reported.

**Measure:** Change in the Amount of Corticosteroid Required Over Time

**Time Frame:** Baseline, Weeks 24, 48, 96, and 144

**Description:** 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).

**Measure:** Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Scale Score

**Time Frame:** Up to 3 year 6 months

**Description:** 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.

**Measure:** Number of Participants With Treatment-emergent Adverse Events (TEAEs)

**Time Frame:** Up to 3 year 6 months

**Description:** AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of ibrutinib.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of ibrutinib.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC [0-24]) of Ibrutinib

**Time Frame:** 0 to 24 hours (Day 1 of Weeks 1 and 2)

**Description:** Cmax is defined as maximum observed plasma concentration of ibrutinib.

**Measure:** Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** Tmax is defined as time to reach the maximum observed plasma concentration of ibrutinib.

**Measure:** Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** T1/2 is defined as elimination half-life of ibrutinib.

**Measure:** Elimination Half-Life (t1/2) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** CL/F is defined as apparent clearance of ibrutinib.

**Measure:** Apparent Clearance (CL/F) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** Vd/F is defined as apparent volume of distribution of ibrutinib.

**Measure:** Apparent Volume of Distribution (Vd/F) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of ibrutinib.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ibrutinib

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** 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.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of PCI-45227.

**Measure:** Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of PCI-45227

**Time Frame:** 0 to 24 hours (Day 1 of Weeks 1 and 2)

**Description:** Cmax is defined as maximum observed plasma concentration of PCI-45227.

**Measure:** Maximum Observed Plasma Concentration (Cmax) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** Tmax is defined as time to reach the maximum observed plasma concentration of PCI-45227.

**Measure:** Time to Reach Maximum Observed Plasma Concentration (Tmax) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** T1/2 is defined as elimination half-life of PCI-45227.

**Measure:** Elimination Half-Life (t1/2) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** CL/F is defined as apparent clearance of PCI-45227.

**Measure:** Apparent Clearance (CL/F) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** Vd/F is defined as apparent volume of distribution of PCI-45227.

**Measure:** Apparent Volume of Distribution (Vd/F) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

**Description:** AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of PCI-45227.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of PCI-45227

**Time Frame:** Day 1 of Weeks 1 and 2

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as modified National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT): a) Dependent disease, defined as, when glucocorticoid (prednisolone doses greater than or equal to \[\>=\] 0.25 milligram per kilogram per day (mg/kg/day)or \>=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks. In case of inability to taper the dose to less than or equal to (\<=)0.25 mg/kg/day or \<=0.5 mg/kg every other day (prednisolone doses) due to recurrence or progression of cGVHD manifestations, it is considered as steroid-dependent disease if the lowest tapering dose of the second occasion is equal or higher than the lowest tapering dose of the first occasion; b) Refractory disease, defined as, when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at \>=1 mg/kg/day for at least 1 week) or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks
* Participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry. The dose of steroids must be stable for 14 days prior to starting ibrutinib
* At the time of trial enrollment, participants may be receiving other immunosuppressive therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for 14 days prior to starting ibrutinib
* Clinically stable or worsening cGVHD for a minimum of 14 days between screening and Day 1 cGVHD response assessment
* Karnofsky or Lansky (participants less than \[\<\]16 years) performance status \>=60

Exclusion Criteria:

* Active acute graft versus host disease (GVHD)
* More than 3 previous systemic treatments for cGVHD. Treatment with glucocorticoids is considered a treatment for cGVHD and should be included in determining the number of previous treatments
* History of treatment with a tyrosine kinase inhibitor (example \[e.g.\] imatinib), purine analogs, or other cancer chemotherapy in the 4 weeks prior to starting ibrutinib. Participants may have received ibrutinib pre-transplant for other reasons besides cGVHD such as for the treatment of leukemia or lymphoma
* History of treatment with monoclonal T and B cell antibodies in the 8 weeks prior to starting ibrutinib
* Vaccinated with live, attenuated vaccines within 4 weeks of first dose of ibrutinib

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Anjo-shi

**Country:** Japan

**Facility:** Anjo Kosei Hospital

**Zip:** 446-8602

**Location 2:**

**City:** Bunkyo-ku

**Country:** Japan

**Facility:** Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

**Zip:** 113-8677

**Location 3:**

**City:** Hiroshima

**Country:** Japan

**Facility:** Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

**Zip:** 730-8619

**Location 4:**

**City:** Hyogo

**Country:** Japan

**Facility:** Kobe City Medical Center General Hospital

**Zip:** 650-0047

**Location 5:**

**City:** Isehara

**Country:** Japan

**Facility:** Tokai University Hospital

**Zip:** 259-1193

**Location 6:**

**City:** Izumi

**Country:** Japan

**Facility:** Osaka Women's and Children's Hospital

**Zip:** 594-1101

**Location 7:**

**City:** Kumamoto-shi

**Country:** Japan

**Facility:** National Hospital Organization Kumamoto Medical Center

**Zip:** 860-0008

**Location 8:**

**City:** Kurashiki

**Country:** Japan

**Facility:** Kurashiki Central Hospital

**Zip:** 710-8602

**Location 9:**

**City:** Maebashi

**Country:** Japan

**Facility:** Gunmaken Saiseikai Maebashi Hospital

**Zip:** 371-0821

**Location 10:**

**City:** Nagoya

**Country:** Japan

**Facility:** Japanese Red Cross Nagoya Daiichi Hospital

**Zip:** 453-8511

**Location 11:**

**City:** Nishinomiya

**Country:** Japan

**Facility:** The Hospital of Hyogo College of Medicine

**Zip:** 663-8501

**Location 12:**

**City:** Okayama

**Country:** Japan

**Facility:** Okayama University Hospital

**Zip:** 700-8558

**Location 13:**

**City:** Osaka

**Country:** Japan

**Facility:** Osaka City University Hospital

**Zip:** 545-8586

**Location 14:**

**City:** Sapporo-shi

**Country:** Japan

**Facility:** Hokkaido University Hospital

**Zip:** 060-8648

**Location 15:**

**City:** Setagaya-ku

**Country:** Japan

**Facility:** National Center for Child Health and Development

**Zip:** 157-8535

#### Overall Officials

**Official 1:**

**Affiliation:** Janssen Pharmaceutical K.K.

**Name:** Janssen Pharmaceutical K.K., Japan Clinical Trial

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 34102349

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-07-24

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 2580413

- Type Abbrev: Prot

- Upload Date: 2022-11-27T23:39

- Date: 2022-01-13

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 956899

- Type Abbrev: SAP

- Upload Date: 2022-11-27T23:39

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

- ID: D000092124

- Term: Organizing Pneumonia

- ID: D000001989

- Term: Bronchiolitis Obliterans

- ID: D000001988

- Term: Bronchiolitis

- ID: D000001991

- Term: Bronchitis

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9189

- Name: Graft vs Host Disease

- Relevance: HIGH

- As Found: Graft vs Host Disease

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M5264

- Name: Bronchiolitis

- Relevance: LOW

- As Found: Unknown

- ID: M2893

- Name: Bronchiolitis Obliterans Syndrome

- Relevance: HIGH

- As Found: Chronic Graft Versus Host Disease

- ID: M5265

- Name: Bronchiolitis Obliterans

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M2894

- Name: Organizing Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M5267

- Name: Bronchitis

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic Graft Versus Host Disease

- ID: T2832

- Name: Homologous Wasting Disease

- Relevance: HIGH

- As Found: Graft Versus Host Disease

- ID: T871

- Name: Bronchiolitis Obliterans

- Relevance: LOW

- As Found: Unknown

- ID: T872

- Name: Bronchiolitis Obliterans Organizing Pneumonia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000092122

- Term: Bronchiolitis Obliterans Syndrome

- ID: D000006086

- Term: Graft vs Host Disease

### Intervention Browse Module - Ancestors

- ID: D000092004

- Term: Tyrosine Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M42179

- Name: Ibrutinib

- Relevance: HIGH

- As Found: Effective

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000551803

- Term: Ibrutinib

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2022-12-27

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

#### Event Groups

**Group ID:** EG000

**Title:** Ibrutinib 420 mg

**Deaths Num Affected:** 7

**Deaths Num At Risk:** 19

**Description:** 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.

**ID:** EG000

**Other Num Affected:** 19

**Other Num at Risk:** 19

**Serious Number Affected:** 12

**Serious Number At Risk:** 19

**Title:** Ibrutinib 420 mg

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Immune Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Increased Tendency to Bruise

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Iron Deficiency Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Splenic Infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cardiac Failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cardiac Failure Chronic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypothyroidism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cataract

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Conjunctival Erosion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Conjunctival Hyperaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Dry Eye

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Glaucoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Ocular Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Photophobia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Abdominal Pain Upper

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Ascites

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cheilitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Dental Caries

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Enterocolitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Gastric Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Gastric Mucosal Hypertrophy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Gastrointestinal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Stomatitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Tooth Loss

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Generalised Oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Malaise

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Oedema Peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Physical Deconditioning

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hepatic Function Abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Liver Disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Food Allergy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypogammaglobulinaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Seasonal Allergy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Appendiceal Abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Bronchiolitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cellulitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Conjunctivitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cytomegalovirus Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Haematoma Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Herpes Zoster

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Impetigo

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Nasopharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Oral Candidiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Otitis Externa

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Paronychia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pneumonia Aspiration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pneumonia Bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pneumonia Fungal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Postoperative Wound Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pseudomembranous Colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pyelonephritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Sinusitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Anaemia Postoperative

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Atypical Femur Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Bone Contusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Contusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Joint Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Procedural Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Skin Abrasion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Skin Laceration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Tooth Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Traumatic Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Alanine Aminotransferase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Amylase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Aspergillus Test Positive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Blood Beta-D-Glucan Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Blood Creatinine Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Blood Fibrinogen Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Blood Lactate Dehydrogenase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Gamma-Glutamyltransferase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Haemoglobin Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Lipase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Lymphocyte Count Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Neutrophil Count Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Platelet Count Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Weight Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Weight Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Decreased Appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hyperkalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypertriglyceridaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hyperuricaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypoalbuminaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypocalcaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypoglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypokalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Lipid Metabolism Disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Zinc Deficiency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Back Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Immobilisation Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Metatarsalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Muscle Spasms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Osteonecrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Osteonecrosis of Jaw

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Osteoporosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Rheumatoid Arthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Spinal Osteoarthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Acute Lymphocytic Leukaemia Recurrent

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pyogenic Granuloma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypoaesthesia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Intercostal Neuralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Restless Legs Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Toxic Encephalopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Anxiety

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Chronic Kidney Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Haematuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Urinary Retention

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Benign Prostatic Hyperplasia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Asthma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Epistaxis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Oropharyngeal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pleural Effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Acne

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Dermal Cyst

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Dermatitis Acneiform

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Drug Eruption

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Dry Skin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Eczema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Haemorrhage Subcutaneous

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Ingrowing Nail

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Purpura

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Skin Atrophy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Skin Exfoliation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Skin Induration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Skin Ulcer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Toxic Skin Eruption

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 24.1

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 24.1

#### Serious Events

**Term:** Immune Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Atrial Flutter

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Cataract

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Gastrointestinal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Multiple Organ Dysfunction Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Liver Disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Anaphylactic Reaction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Appendiceal Abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Bronchiolitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Cellulitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 19

**Term:** Covid-19

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 19

**Term:** Pneumonia Bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Pneumonia Fungal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Pyelonephritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Septic Shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Atypical Femur Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Diabetes Mellitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Hyperkalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Osteonecrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Subarachnoid Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 19

**Term:** Renal Impairment

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 19

**Time Frame:** Up to 3 year 6 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 19

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ibrutinib 420 mg

**Description:** 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.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 16.24

**Value:** 40.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Less Than or Equal to 17 years (adolescent)

#### Measurement

**Group ID:** BG000

**Value:** 18

**Category Title:** From 18 to 64 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 19

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 19

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 19

**Class Title:** JAPAN

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialDisclosure@its.jnj.com
**Organization:** Janssen Pharmaceutical K.K.
**Phone:** 844-434-4210
**Title:** EXECUTIVE MEDICAL DIRECTOR
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68.8
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** Here, 'NA' indicates that median and upper limit of 95% confidence interval were not estimable due to the less number of events.
- **Group ID:** OG000
- **Lower Limit:** 5.30
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.1
- **Spread:** 
- **Upper Limit:** 51.2
- **Value:** 26.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.3
- **Spread:** 
- **Upper Limit:** 66.5
- **Value:** 42.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.9
- **Spread:** 
- **Upper Limit:** 75.6
- **Value:** 52.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.4
- **Spread:** 
- **Upper Limit:** 71.1
- **Value:** 47.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.4
- **Spread:** 
- **Upper Limit:** 71.1
- **Value:** 47.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.3
- **Spread:** 
- **Upper Limit:** 66.5
- **Value:** 42.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.3
- **Spread:** 
- **Upper Limit:** 61.6
- **Value:** 36.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.6
- **Spread:** 
- **Upper Limit:** 56.6
- **Value:** 31.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.6
- **Spread:** 
- **Upper Limit:** 56.6
- **Value:** 31.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.6
- **Spread:** 
- **Upper Limit:** 56.6
- **Value:** 31.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.3
- **Spread:** 
- **Upper Limit:** 61.6
- **Value:** 36.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.6
- **Spread:** 
- **Upper Limit:** 56.6
- **Value:** 31.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.1
- **Spread:** 
- **Upper Limit:** 51.2
- **Value:** 26.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.3
- **Spread:** 
- **Upper Limit:** 33.1
- **Value:** 10.5
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.08
- **Spread:** 
- **Upper Limit:** 1.77
- **Value:** 0.270
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.08
- **Spread:** 
- **Upper Limit:** 0.87
- **Value:** 0.250
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.06
- **Spread:** 
- **Upper Limit:** 0.64
- **Value:** 0.150
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.01
- **Spread:** 
- **Upper Limit:** 0.59
- **Value:** 0.140
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.05
- **Spread:** 
- **Upper Limit:** 0.56
- **Value:** 0.140
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.9
- **Spread:** 
- **Upper Limit:** 75.6
- **Value:** 52.6
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3146.9
- **Upper Limit:** 
- **Value:** 3683.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4287.2
- **Upper Limit:** 
- **Value:** 4024.8
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1797.4
- **Upper Limit:** 
- **Value:** 2929.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4277.2
- **Upper Limit:** 
- **Value:** 4035.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 366.07
- **Upper Limit:** 
- **Value:** 490.45
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 508.08
- **Upper Limit:** 
- **Value:** 478.01
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.78
- **Spread:** 
- **Upper Limit:** 5.75
- **Value:** 3.87
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.75
- **Spread:** 
- **Upper Limit:** 5.43
- **Value:** 4.02
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.4
- **Spread:** 
- **Upper Limit:** 5.2
- **Value:** 4.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.8
- **Spread:** 
- **Upper Limit:** 10.2
- **Value:** 4.4
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 106164
- **Upper Limit:** 
- **Value:** 194211
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 31966
- **Upper Limit:** 
- **Value:** 162457
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 748511
- **Upper Limit:** 
- **Value:** 1350160
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
**Units:** Participants
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1656.2
- **Upper Limit:** 
- **Value:** 2643.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 506.57
- **Upper Limit:** 
- **Value:** 2659.2
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 968.83
- **Upper Limit:** 
- **Value:** 1976.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 999.00
- **Upper Limit:** 
- **Value:** 2547.6
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 585.84
- **Upper Limit:** 
- **Value:** 1803.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 999.00
- **Upper Limit:** 
- **Value:** 2547.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
**Units:** Participants
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 91.874
- **Upper Limit:** 
- **Value:** 185.37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 82.292
- **Upper Limit:** 
- **Value:** 203.16
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.88
- **Spread:** 
- **Upper Limit:** 6.18
- **Value:** 4.00
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 5.28
- **Value:** 4.02
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.2
- **Spread:** 
- **Upper Limit:** 6.5
- **Value:** 5.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.4
- **Spread:** 
- **Upper Limit:** 5.4
- **Value:** 5.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 68392
- **Upper Limit:** 
- **Value:** 251681
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** Here, 'NA' indicates that standard deviation could not be calculated for a single participant.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** 111922
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 653626
- **Upper Limit:** 
- **Value:** 2148283
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
**Units:** Participants
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 478.74
- **Upper Limit:** 
- **Value:** 1766.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** Here, 'NA' indicates that standard deviation could not be calculated for a single participant.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** 3752.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Parameter Type:** NUMBER
**Population Description:** All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Up to 3 year 6 months
**Title:** Overall Response Rate (ORR)
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** NUMBER
**Population Description:** All treated analysis set included all enrolled participants who received at least 1 dose of study drug and achieved PR or better response.
**Reporting Status:** POSTED
**Time Frame:** Up to 3 year 6 months
**Title:** Sustained Response Rate
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 3
**Description:** 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.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** All treated analysis set included all enrolled participants who received at least 1 dose of study drug and achieved PR or better response.
**Reporting Status:** POSTED
**Time Frame:** Up to 3 year 6 months
**Title:** Duration of Response (DOR)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 4
**Description:** 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.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Weeks 5, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157
**Title:** cGVHD Response Rate at Each Timepoints
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 5
**Description:** Change in the amount of corticosteroid required over time was reported.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 24, 48, 96, and 144
**Title:** Change in the Amount of Corticosteroid Required Over Time
**Type:** SECONDARY
**Unit of Measure:** Milligrams per kilograms per day
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 6
**Description:** 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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Up to 3 year 6 months
**Title:** Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Scale Score
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 7
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Up to 3 year 6 months
**Title:** Number of Participants With Treatment-emergent Adverse Events (TEAEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 8
**Description:** AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of ibrutinib.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** hours*nanograms per milliliter (h*ng/mL)
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 9
**Description:** AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of ibrutinib.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 0 to 24 hours (Day 1 of Weeks 1 and 2)
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC [0-24]) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** hour*ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 10
**Description:** Cmax is defined as maximum observed plasma concentration of ibrutinib.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** Nanograms per milliliter (ng/mL)
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 11
**Description:** Tmax is defined as time to reach the maximum observed plasma concentration of ibrutinib.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** Hours
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 12
**Description:** T1/2 is defined as elimination half-life of ibrutinib.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Elimination Half-Life (t1/2) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** Hours
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 13
**Description:** CL/F is defined as apparent clearance of ibrutinib.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Apparent Clearance (CL/F) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** Milliliters per hour (mL/h)
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 14
**Description:** Vd/F is defined as apparent volume of distribution of ibrutinib.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Apparent Volume of Distribution (Vd/F) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** Milliliters (mL)
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 15
**Description:** AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of ibrutinib.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ibrutinib
**Type:** SECONDARY
**Unit of Measure:** hour*ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 16
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** h*ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 17
**Description:** AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of PCI-45227.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 0 to 24 hours (Day 1 of Weeks 1 and 2)
**Title:** Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** hour*ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 18
**Description:** Cmax is defined as maximum observed plasma concentration of PCI-45227.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Maximum Observed Plasma Concentration (Cmax) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 19
**Description:** Tmax is defined as time to reach the maximum observed plasma concentration of PCI-45227.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Time to Reach Maximum Observed Plasma Concentration (Tmax) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** Hours
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 20
**Description:** T1/2 is defined as elimination half-life of PCI-45227.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Elimination Half-Life (t1/2) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** Hours
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 21
**Description:** CL/F is defined as apparent clearance of PCI-45227.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Apparent Clearance (CL/F) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** mL/h
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 22
**Description:** Vd/F is defined as apparent volume of distribution of PCI-45227.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Apparent Volume of Distribution (Vd/F) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
#### Outcome Measure 23
**Description:** AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of PCI-45227.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Day 1 of Weeks 1 and 2
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of PCI-45227
**Type:** SECONDARY
**Unit of Measure:** hour*ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Ibrutinib 420 mg
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Ibrutinib 420 mg
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 19
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
**Has Results:** True