GRAVITAS-309: Itacitinib and Corticosteroids as Initial T... | NCT03584516 | Trialant
NCT03584516
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Oct 20, 2025Actual
Enrollment
155Actual
Phase
Phase 2Phase 3
Conditions
Chronic Graft-versus-host Disease
Interventions
Itacitinib
Placebo
Methylprednisolone
Prednisone
Countries
United States
Austria
Belgium
Canada
Denmark
Finland
France
Germany
Greece
Israel
Italy
Poland
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03584516
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 39110-309
Secondary IDs
ID
Type
Description
Link
2018-001606-29
EudraCT Number
Brief Title
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Official Title
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.
Expanded Access Info
No
Start Date
Jan 17, 2019Actual
Primary Completion Date
Nov 3, 2023Actual
Completion Date
Nov 3, 2023Actual
First Submitted Date
Jun 29, 2018
First Submission Date that Met QC Criteria
Jun 29, 2018
First Posted Date
Jul 12, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 8, 2024
Results First Submitted that Met QC Criteria
Jan 24, 2025
Results First Posted Date
Jan 27, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 15, 2025
Last Update Posted Date
Oct 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Graft-versus-host Disease
Keywords
Graft-versus-host-disease
itacitinib
Janus kinase inhibitor
corticosteroids
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
155Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 : Dose determination of itacitinib
Experimental
itacitinib administered in combination with corticosteroids.
Drug: Itacitinib
Drug: Methylprednisolone
Drug: Prednisone
Part 1 : Dose expansion of itacitinib
Experimental
itacitinib administered in combination with corticosteroids or corticosteroids alone.
Drug: Itacitinib
Drug: Placebo
Drug: Methylprednisolone
Drug: Prednisone
Part 2 : itacitinib recommended dose from part 1
Placebo Comparator
itacitinib or placebo administered in combination with corticosteroids
Drug: Itacitinib
Drug: Methylprednisolone
Drug: Prednisone
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Itacitinib
Drug
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification.
up to Day 28
Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
until at least 30 days after the last dose of study treatment (up to 1103 days)
Part 2: Response Rate at Month 6
Response rate was defined as the percentage of participants that had complete response (CR) or partial response (PR), per National Institutes of Health (NIH) Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Month 6
Secondary Outcomes
Measure
Description
Time Frame
Part 1 Expansion: Response Rate at Months 3 and 6
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria:
Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP).
Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence.
Evidence of relapsed primary malignancy.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Rodica Morariu-Zamfir, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Arizona Cancer Center - Out Pt.
Tucson
Arizona
85724
United States
University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 65 study centers in Austria, Belgium, Canada, Denmark, Germany, Greece, Israel, Italy, Poland, Spain, Switzerland, United Kingdom, and the United States.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Itacitinib 200 mg QD + CS
Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 30, 2021
Oct 8, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
In Part 2 of the study, participants in the placebo group will be allowed to cross over to the experimental group after completion of the primary analysis.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Part 1 : Dose determination of itacitinib
Part 1 : Dose expansion of itacitinib
Part 2 : itacitinib recommended dose from part 1
INCB039110
Placebo
Drug
In Part 2, participants will receive matching placebo.
Part 1 : Dose expansion of itacitinib
Methylprednisolone
Drug
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Part 1 : Dose determination of itacitinib
Part 1 : Dose expansion of itacitinib
Part 2 : itacitinib recommended dose from part 1
Medrol, Medrol Dosepak, Solu-Medrol
Prednisone
Drug
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Cmax was defined as the maximum observed concentration of itacitinib.
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
Parts 1 and 1 Expansion: Ctau of Itacitinib
Ctau was defined as the trough concentration of itacitinib over the dose interval. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.
Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)
Parts 1 and 1 Expansion: Tmax of Itacitinib
tmax was defined as the time to the maximum concentration of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.
Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)
Parts 1 and 1 Expansion: Cl/F of Itacitinib
Cl/F was defined as the apparent oral dose clearance of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.
Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)
Part 2: Cmax of Itacitinib
Cmax was defined as the maximum observed concentration of itacitinib.
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
Part 2: Cmin of Itacitinib
Cmin was defined as the minimum observed plasma or serum concentration of itacitinib over the dose interval.
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
Part 2: Tmax of Itacitinib
tmax was defined as the time to the maximum concentration of itacitinib.
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
Part 2: AUC0-t of Itacitinib
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
Part 2: Cl/F of Itacitinib
Cl/F was defined as the apparent oral dose clearance of itacitinib.
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
Part 1: Response Rate at Months 3, 6, and 12
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Months 3, 6, and 12
Part 1 Expansion: Response Rate at Month 12
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Month 12
Part 1 Expansion: Time to Response
Time to response was defined as the interval between randomization and the first response (CR or PR) before initiation of new therapy. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
up to Month 12
Part 1 Expansion: Duration of Response
Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy.
up to 24 months
Part 1 Expansion: Overall Survival
Overall survival was defined as the interval between the date of randomization and the date of death due to any cause.
up to 36 months
Part 1 Expansion: Nonrelapse Mortality (NRM) Rate
NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease.
up to 24 months
Part 1 Expansion: Percentage of Participants With a ≥50% Reduction in Daily Corticosteroid Dose at Day 180 From the Corticosteroid Dose on Day 1
The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction.
Day 1; Day 180
Part 1 Expansion: Percentage of Participants Successfully Tapered Off All Corticosteroids at Day 180
The percentage of participants who were not taking any corticosteroids at Day 180 was assessed.
Day 180
Part 1 Expansion: Relapse Rate of Malignant and Nonmalignant Hematologic Diseases
The relapse rate was defined as the percentage of participants whose underlying disease relapsed at any time during the course of the study.
up to 1073 days
Part 1 Expansion: Time to Primary Hematologic Disease Relapse
Time to primary hematologic disease relapse was defined as the interval between the date of randomization and the date of relapse.
up to 24 months
Part 2: Change From Baseline in Lee cGVHD Symptom Scale (LLS) Scores
The LSS consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Baseline; End of Treatment in Phase 2
Part 2: Change From Baseline in Quality of Life-Short Form-36 Version 2 (QOL-SF-36 v2) Scores
The QOL-SF-36 v2 is 36-item scale that captures changes in health status during the course of treatment. The SF-36 assesses 8 health concepts related to limitations in physical activities, social activities, bodily pain, general mental and physical health, and vitality. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Baseline; End of Treatment in Phase 2
Part 2: Change From Baseline in EQ-5D-3L Scores
The EQ-5D-3L is a descriptive classification consisting of 5 dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Baseline; End of Treatment in Phase 2
Part 2: Change From Baseline in Patient Global Impression of Change (PGIC) Responses
The PGIC is 1 question that captures the overall change in symptoms over the course of treatment. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Baseline; End of Treatment in Phase 2
Part 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Responses
The PGIS is 1 question that captures the overall change in the severity of symptoms over the previous week. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Baseline; End of Treatment in Phase 2
Part 2: Response Rate at Months 3 and 12
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Months 3 and 12
Part 2: Duration of Response
Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy.
up to 24 months
Part 2: Overall Survival
Overall survival was defined as the interval between the date of randomization and the date of death due to any cause.
up to 36 months
Part 2: NRM Rate
NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease.
up to 24 months
Part 2: Percentage of Participants With a ≥50% Reduction in Daily Corticosteroid Dose at Day 180 From the Corticosteroid Dose on Day 1
The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction.
Day 1; Day 180
Part 2: Percentage of Participants Successfully Tapered Off All Corticosteroids at Day 180
The percentage of participants who were not taking any corticosteroids at Day 180 was assessed.
Day 180
Part 2: Relapse Rate of Malignant and Nonmalignant Hematologic Diseases
The relapse rate was defined as the defined as the percentage of participants whose underlying disease relapsed at any time during the course of the study.
up to 24 months
Part 2: Time to Primary Hematologic Disease Relapse
Time to primary hematologic disease relapse was defined as the interval between the date of randomization and the date of relapse.
up to 24 months
Part 2: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
up to 30 days after the last dose in Phase 2
Little Rock
Arkansas
72205
United States
City of Hope National Medical Center
Duarte
California
91010
United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla
California
92093
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami
Florida
33136-1002
United States
Winship Cancer Institute of Emory University
Atlanta
Georgia
30322
United States
Augusta University - Medical College of Georgia
Augusta
Georgia
30912
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
Illinois Cancer Specialists
Chicago
Illinois
60714
United States
Loyola University Medical Center
Maywood
Illinois
60153-3328
United States
Advocate Lutheran General Hospital - Oncology Specislists Sc
Park Ridge
Illinois
60028
United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis
Indiana
46202-5201
United States
University of Kansas Hospital Authority
Westwood
Kansas
66160
United States
Tulane University
New Orleans
Louisiana
70112-2618
United States
University of Maryland - Greenebaum Cancer Center
Baltimore
Maryland
21201
United States
Tufts Medical Center
Boston
Massachusetts
02111-1552
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
Spectrum Health
Grand Rapids
Michigan
49503
United States
University of Minnesota, Masonic Cancer Center
Minneapolis
Minnesota
55455
United States
Saint Louis University Cancer Center
St Louis
Missouri
63110
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601-8550
United States
University of Rochester, James P. Wilmot Cancer Center
Rochester
New York
14642-0001
United States
Stony Brook University Medical Center
Stony Brook
New York
11794
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Oncology Hematology Care, Inc
Cincinnati
Ohio
45236
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106-1716
United States
University of Pennsylvania Abramson Cancer Center
Philadelphia
Pennsylvania
19104
United States
Jefferson University Hospitals
Philadelphia
Pennsylvania
19107
United States
Western Pennsylvania Hospital
Pittsburgh
Pennsylvania
15224
United States
University of Pittsburgh
Pittsburgh
Pennsylvania
15232-1309
United States
Avera Cancer Institute
Sioux Falls
South Dakota
57105-2108
United States
Tri Star Bone Marrow Transplant
Nashville
Tennessee
37203
United States
Vanderbilt-Ingram Cancer Center
Nashville
Tennessee
37232
United States
St David'S South Austin Medical Center
Austin
Texas
78704
United States
Texas Oncology - Medical City Dallas
Dallas
Texas
75230
United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas
Texas
75246
United States
Fred Hutchinson Cancer Research Center
Seattle
Washington
98109
United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz
04020
Austria
Zna Stuivenberg
Antwerp
02060
Belgium
Institut Jules Bordet
Brussels
01000
Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem
02650
Belgium
Universitair Ziekenhuis Gent
Ghent
09000
Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven
03000
Belgium
CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN
Liège
04000
Belgium
AZ DELTA
Roeselare
08800
Belgium
University of Alberta
Edmonton
Alberta
T6G 2P4
Canada
University Health Network
Toronto
Ontario
M5G 2M9
Canada
Hospital Maisonneuve Rosemont
Montreal
Quebec
H1T 2M4
Canada
Saskatchewan Cancer
Saskatoon
Saskatchewan
S7N 4H4
Canada
The Finsen Centre National Hospital
Copenhagen
02100
Denmark
Turku University Hospital
Turku
20521
Finland
Chu Amiens Picardie - Hopital Sud
Amiens
80054
France
Centre Hospitalier D'Angers
Angers
49000
France
Chu de Grenoble - Hopital Albert Michallon
Grenoble
38700
France
Institut Paoli-Calmettes
Marseille
13273
France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes
44000
France
Chu de Nice - Hospital L Archet
Nice
06800
France
Chu de Rennes - Hospital Pontchaillou
Rennes
35033
France
Centre Henri Becquerel
Rouen
76038
France
Chru Hopitaux de Tours Hospital Bretonneau
Tours
37000
France
Hopitaux de Brabois
Vandœuvre-lès-Nancy
54511
France
Charite Berlin
Berlin
12200
Germany
Universitatsklinikum Bonn Aoer
Bonn
00011
Germany
Universitatsklinikum Koln
Cologne
50937
Germany
University Clinic Carl Gustav Carus Technical University Dresden
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
Roma
00161
Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Roma
00168
Italy
Irrcs Instituto Clinico Humanitas
Rozzano
20089
Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo
71013
Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino
10126
Italy
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
Udine
33100
Italy
Centro Ricerche Cliniche Di Verona (Crc)
Verona
37134
Italy
Uniwersyteckie Centrum Kliniczne
Gdansk
80-592
Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi
Gliwice
44-101
Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan
60-569
Poland
Mtz Clinical Research Sp. Zo.O.
Warsaw
02-106
Poland
Institut Catala D Oncologia
Badalona
08916
Spain
Hospital de La Santa Creu I Sant Pau
Barcelona
08041
Spain
Hospital Universitario Virgen de Las Nieves
Granada
18014
Spain
Ico Institut Catala D Oncologia
L'Hospitalet de Llobregat
08908
Spain
Hospital General Universitario Gregorio Maranon
Madrid
28007
Spain
Hospital Universitario Ramon Y Cajal
Madrid
28034
Spain
Hospital Regional Universitario de Malaga
Málaga
29010
Spain
Son Espases University Hospital
Palma
07120
Spain
Clinica Universidad de Navarra (Cun)
Pamplona
31008
Spain
Hospital Clinico Universitario de Salamanca
Salamanca
37007
Spain
Hospital Universitario Marques de Valdecilla
Santander
39008
Spain
Hospital Clinico de Santiago de Compostela
Santiago de Compostela
15706
Spain
Hospital Universitario Y Politcnico de La Fe
Valencia
46009
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
Karolinska University Hospital Huddinge
Huddinge
141 86
Sweden
Skane University Hospital Lund
Lund
22185
Sweden
Universitatsspital Zurich
Zurich
08091
Switzerland
Bristol Haematology & Oncology Centre
Bristol
BS2 8ED
United Kingdom
University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom
Barts Health Nhs Trust - St Bartholomews Hospital
London
EC1A 7BE
United Kingdom
King'S College Hospital (Nhs Foundation)
London
SE5 9RS
United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London
W12 0HS
United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham
NG5 1PB
United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton
SM2 5PT
United Kingdom
St. George'S University Hospitals Nhs Foundation Trust
Tooting
SW17 0QT
United Kingdom
FG001
Part 1: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
FG002
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
FG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
FG004
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
FG005
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
FG00011 subjects
FG00110 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0006 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1 Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00235 subjects
FG00339 subjects
FG00429 subjects
FG00536 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00232 subjects
FG00337 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0029 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Itacitinib 200 mg QD + CS
Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
BG001
Part 1: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
BG002
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
BG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
BG004
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
BG005
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00110
BG00235
BG00339
BG00429
BG00536
BG006160
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.2± 7.07
BG00158.4± 15.08
BG00253.6± 14.01
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG00011
BG0018
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0004
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification.
Safety Analysis Set: all enrolled/randomized participants who received at least 1 dose of study drug and/or reference therapy. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment.
Posted
Count of Participants
Participants
up to Day 28
ID
Title
Description
OG000
Part 1: Itacitinib 200 mg QD + CS
Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
Primary
Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Safety Analysis Set
Posted
Count of Participants
Participants
until at least 30 days after the last dose of study treatment (up to 1103 days)
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Primary
Part 2: Response Rate at Month 6
Response rate was defined as the percentage of participants that had complete response (CR) or partial response (PR), per National Institutes of Health (NIH) Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Month 6
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 1 Expansion: Response Rate at Months 3 and 6
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Months 3 and 6
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Parts 1 and 1 Expansion: Cmax of Itacitinib
Cmax was defined as the maximum observed concentration of itacitinib.
Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and/or reference therapy and provided at least 1 corresponding post-dose plasma sample (1 PK measurement). Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm).
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomoles per Liter (nmol/L)
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
ID
Title
Description
OG000
Parts 1 and 1 Expansion: 100 mg QD + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 200 mg or 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg QD + CS and/or dose interruptions.
OG001
Parts 1 and 1 Expansion: Itacitinib 200 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 200 mg QD + CS in Part 1 or had a dose reduction to oral itacitinib 200 mg QC + CS in Part 1 or Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 200 mg QD + CS and/or dose interruptions.
Secondary
Parts 1 and 1 Expansion: Ctau of Itacitinib
Ctau was defined as the trough concentration of itacitinib over the dose interval. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.
PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)
ID
Title
Description
OG000
Parts 1 and 1 Expansion: 100 mg QD + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 200 mg or 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg QD + CS and/or dose interruptions.
OG001
Secondary
Parts 1 and 1 Expansion: Tmax of Itacitinib
tmax was defined as the time to the maximum concentration of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.
PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm).
Posted
Median
Full Range
hours
Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)
ID
Title
Description
OG000
Parts 1 and 1 Expansion: 100 mg QD + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 200 mg or 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg QD + CS and/or dose interruptions.
OG001
Parts 1 and 1 Expansion: Itacitinib 200 mg QD + CS
Secondary
Parts 1 and 1 Expansion: Cl/F of Itacitinib
Cl/F was defined as the apparent oral dose clearance of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.
PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm).
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)
ID
Title
Description
OG000
Parts 1 and 1 Expansion: 100 mg QD + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 200 mg or 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg QD + CS and/or dose interruptions.
OG001
Secondary
Part 2: Cmax of Itacitinib
Cmax was defined as the maximum observed concentration of itacitinib.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Cmin of Itacitinib
Cmin was defined as the minimum observed plasma or serum concentration of itacitinib over the dose interval.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Tmax of Itacitinib
tmax was defined as the time to the maximum concentration of itacitinib.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: AUC0-t of Itacitinib
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Cl/F of Itacitinib
Cl/F was defined as the apparent oral dose clearance of itacitinib.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 1: Response Rate at Months 3, 6, and 12
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Months 3, 6, and 12
ID
Title
Description
OG000
Part 1: Itacitinib 200 mg QD + CS
Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Part 1 Expansion: Response Rate at Month 12
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Month 12
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Part 1 Expansion: Time to Response
Time to response was defined as the interval between randomization and the first response (CR or PR) before initiation of new therapy. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Safety Analysis Set. Participants with a first response of CR or PR up to 12 months, until initiation of new anti-GVHD therapy, relapse of underlying malignancy, or overall response of progression or death were analyzed.
Posted
Median
Full Range
days
up to Month 12
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Part 1 Expansion: Duration of Response
Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy.
Safety Analysis Set. Participants with a first response of CR or PR up to 12 months, until initiation of new anti-GVHD therapy, relapse of underlying malignancy, or overall response of progression or death were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
Posted
Median
95% Confidence Interval
days
up to 24 months
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Part 1 Expansion: Overall Survival
Overall survival was defined as the interval between the date of randomization and the date of death due to any cause.
Safety Analysis Set. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
Posted
Median
95% Confidence Interval
days
up to 36 months
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG002
Secondary
Part 1 Expansion: Nonrelapse Mortality (NRM) Rate
NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease.
Safety Analysis Set. Participants who did not die due to malignancy relapse were analyzed. The 95% confidence interval was calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
up to 24 months
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Part 1 Expansion: Percentage of Participants With a ≥50% Reduction in Daily Corticosteroid Dose at Day 180 From the Corticosteroid Dose on Day 1
The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction.
Safety Analysis Set. Only those participants ongoing in the study at Day 180 were analyzed.
Posted
Number
percentage of participants
Day 1; Day 180
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG002
Secondary
Part 1 Expansion: Percentage of Participants Successfully Tapered Off All Corticosteroids at Day 180
The percentage of participants who were not taking any corticosteroids at Day 180 was assessed.
Safety Analysis Set. Only those participants ongoing in the study at Day 180 were analyzed.
Posted
Number
percentage of participants
Day 180
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Secondary
Part 1 Expansion: Relapse Rate of Malignant and Nonmalignant Hematologic Diseases
The relapse rate was defined as the percentage of participants whose underlying disease relapsed at any time during the course of the study.
Safety Analysis Set. The 95% confidence interval was calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1073 days
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG002
Secondary
Part 1 Expansion: Time to Primary Hematologic Disease Relapse
Time to primary hematologic disease relapse was defined as the interval between the date of randomization and the date of relapse.
Safety Analysis Set, including censored participants. Censored participants didn't have an event of relapse at any time up to the last assessment date. Participants who didn't have an event of hematologic disease relapse were censored at the time of the last assessment. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
Posted
Median
95% Confidence Interval
days
up to 24 months
ID
Title
Description
OG000
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG001
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Secondary
Part 2: Change From Baseline in Lee cGVHD Symptom Scale (LLS) Scores
The LSS consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Baseline; End of Treatment in Phase 2
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Change From Baseline in Quality of Life-Short Form-36 Version 2 (QOL-SF-36 v2) Scores
The QOL-SF-36 v2 is 36-item scale that captures changes in health status during the course of treatment. The SF-36 assesses 8 health concepts related to limitations in physical activities, social activities, bodily pain, general mental and physical health, and vitality. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Baseline; End of Treatment in Phase 2
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Change From Baseline in EQ-5D-3L Scores
The EQ-5D-3L is a descriptive classification consisting of 5 dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Baseline; End of Treatment in Phase 2
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Change From Baseline in Patient Global Impression of Change (PGIC) Responses
The PGIC is 1 question that captures the overall change in symptoms over the course of treatment. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Baseline; End of Treatment in Phase 2
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Responses
The PGIS is 1 question that captures the overall change in the severity of symptoms over the previous week. It was to be used to assess patient-reported changes in health status, symptoms, and well being.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Baseline; End of Treatment in Phase 2
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Response Rate at Months 3 and 12
Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Months 3 and 12
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Duration of Response
Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
up to 24 months
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Overall Survival
Overall survival was defined as the interval between the date of randomization and the date of death due to any cause.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
up to 36 months
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: NRM Rate
NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
up to 24 months
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Percentage of Participants With a ≥50% Reduction in Daily Corticosteroid Dose at Day 180 From the Corticosteroid Dose on Day 1
The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Day 1; Day 180
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Percentage of Participants Successfully Tapered Off All Corticosteroids at Day 180
The percentage of participants who were not taking any corticosteroids at Day 180 was assessed.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
Day 180
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Relapse Rate of Malignant and Nonmalignant Hematologic Diseases
The relapse rate was defined as the defined as the percentage of participants whose underlying disease relapsed at any time during the course of the study.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
up to 24 months
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Time to Primary Hematologic Disease Relapse
Time to primary hematologic disease relapse was defined as the interval between the date of randomization and the date of relapse.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
up to 24 months
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.
Posted
up to 30 days after the last dose in Phase 2
ID
Title
Description
OG000
Part 2: Itacitinib QD + CS
Participants were to be treated with oral itacitinib QD at the recommended Part 2 dose + CS. CS were to be given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose).
Units
Counts
Participants
OG000
Time Frame
until at least 30 days after the last dose of study treatment (up to 1103 days)
Description
Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Itacitinib 200 mg QD + CS
Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
2
11
6
11
11
11
EG001
Part 1: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
3
10
5
10
10
10
EG002
Part 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
9
35
18
35
33
35
EG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
8
39
22
39
37
39
EG004
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
4
29
12
29
27
29
EG005
Part 1 Expansion: Total
Participants received 300 mg QD, 400 mg QD, or 300 mg BID itacitinib plus corticosteroids.
21
103
52
103
97
103
EG006
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
5
36
9
36
31
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0024 events2 affected35 at risk
EG0031 events1 affected39 at risk
EG0040 events0 affected29 at risk
EG0055 events3 affected103 at risk
EG0060 events0 affected36 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Asthenia
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Bronchiolitis obliterans syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Chills
General disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Clostridial sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cystitis viral
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cytomegalovirus oesophagitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Fatigue
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hepatic fibrosis
Hepatobiliary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Herpes zoster cutaneous disseminated
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Ischaemic limb pain
Vascular disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Malaise
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Oedema
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Optic neuritis
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Physical deconditioning
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0023 events2 affected35 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Psychiatric decompensation
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Salmonella sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Sudden death
General disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Systemic infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Urinary tract infection viral
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Venoocclusive disease
Vascular disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG0031 events1 affected39 at risk
EG0042 events2 affected29 at risk
EG0055 events5 affected103 at risk
EG0061 events1 affected36 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0026 events6 affected35 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected10 at risk
EG0027 events5 affected35 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0004 events3 affected11 at risk
EG0012 events2 affected10 at risk
EG00218 events14 affected35 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26
Systematic Assessment
EG0005 events2 affected11 at risk
EG0010 events0 affected10 at risk
EG0025 events3 affected35 at risk
EG003
Asthenia
General disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0025 events4 affected35 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Blepharitis
Eye disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26
Systematic Assessment
EG0003 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 26
Systematic Assessment
EG0003 events3 affected11 at risk
EG0012 events2 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26
Systematic Assessment
EG0006 events3 affected11 at risk
EG0012 events2 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Blood potassium increased
Investigations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0023 events3 affected35 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0024 events4 affected35 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cataract
Eye disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Chest discomfort
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0024 events4 affected35 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events2 affected35 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0026 events3 affected35 at risk
EG003
Cytomegalovirus test positive
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0024 events4 affected35 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0015 events4 affected10 at risk
EG0026 events6 affected35 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Drug level increased
Investigations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Dry eye
Eye disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events2 affected10 at risk
EG0024 events3 affected35 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0003 events3 affected11 at risk
EG0011 events1 affected10 at risk
EG0027 events5 affected35 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Epstein-Barr virus infection reactivation
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0003 events3 affected11 at risk
EG0011 events1 affected10 at risk
EG0023 events1 affected35 at risk
EG003
Fatigue
General disorders
MedDRA 26
Systematic Assessment
EG0004 events4 affected11 at risk
EG0013 events2 affected10 at risk
EG0027 events6 affected35 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Haemoglobin increased
Investigations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Headache
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0012 events2 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hot flush
Vascular disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0003 events3 affected11 at risk
EG0010 events0 affected10 at risk
EG0024 events4 affected35 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events2 affected35 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0013 events2 affected10 at risk
EG0026 events6 affected35 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0024 events4 affected35 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0029 events5 affected35 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0028 events5 affected35 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Influenza like illness
General disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Liver function test increased
Investigations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0024 events2 affected35 at risk
EG003
Microangiopathy
Vascular disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0003 events3 affected11 at risk
EG0014 events4 affected10 at risk
EG0025 events5 affected35 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG00210 events8 affected35 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0028 events5 affected35 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Oedema
General disorders
MedDRA 26
Systematic Assessment
EG0002 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected10 at risk
EG0026 events6 affected35 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Paronychia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0005 events5 affected11 at risk
EG0013 events3 affected10 at risk
EG0026 events6 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events1 affected35 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA 26
Systematic Assessment
EG0002 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0026 events4 affected35 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected35 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0025 events4 affected35 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0002 events1 affected11 at risk
EG0012 events2 affected10 at risk
EG0029 events8 affected35 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0023 events1 affected35 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0026 events4 affected35 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected35 at risk
EG003
Weight increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected35 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 26
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected35 at risk
EG003
Based on preliminary data, Part 2 did not enroll participants. All participants in Part 1 Expansion who were on treatment with either itacitinib 300 or 400 milligrams (mg) once daily (QD) and who were tolerating and continuing to receive benefit from itacitinib had the option to continue itacitinib treatment in the INCB 39110-801 (NCT04640025) roll-over study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00139
OG00229
OG00336
Title
Denominators
Categories
Title
Measurements
OG00034
OG00138
OG00228
OG00332
0
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00139
OG00229
OG00336
Title
Denominators
Categories
Month 3
Title
Measurements
OG00060.0(42.1 to 76.1)
OG00169.2(52.4 to 83.0)
OG00258.6(38.9 to 76.5)
OG00350.0(32.9 to 67.1)
Month 6
Title
Measurements
OG00042.9(26.3 to 60.6)
OG00153.8(37.2 to 69.9)
OG00234.5(17.9 to 54.3)
OG003
OG002
Parts 1 and 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 300 mg QD + CS in Part 1 or Part 1 Expansion or had a dose reduction to oral itacitinib 300 mg QC + CS in Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 400 mg QD + CS in Part 1 Expansion had a dose reduction to itacitinib 300 mg QD + CS and/or dose interruptions.
OG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG004
Part 1 Expansion: Itacitinib 100 mg BID + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.
OG005
Part 1 Expansion: Itacitinib 200 mg BID + CS
Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.
OG006
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG0003
OG00127
OG00235
OG00326
OG0043
OG00514
OG00616
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG00123
ParticipantsOG00235
ParticipantsOG00326
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00616
Title
Measurements
OG000201± NASD cannot be reported for a single participant.
OG001655± 82.9
OG0021050± 87.3
OG003
Day 7
ParticipantsOG0001
ParticipantsOG00127
ParticipantsOG00232
ParticipantsOG00326
Day 28
ParticipantsOG0003
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00321
Parts 1 and 1 Expansion: Itacitinib 200 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 200 mg QD + CS in Part 1 or had a dose reduction to oral itacitinib 200 mg QC + CS in Part 1 or Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 200 mg QD + CS and/or dose interruptions.
OG002
Parts 1 and 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 300 mg QD + CS in Part 1 or Part 1 Expansion or had a dose reduction to oral itacitinib 300 mg QC + CS in Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 400 mg QD + CS in Part 1 Expansion had a dose reduction to itacitinib 300 mg QD + CS and/or dose interruptions.
OG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG004
Part 1 Expansion: Itacitinib 100 mg BID + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.
OG005
Part 1 Expansion: Itacitinib 200 mg BID + CS
Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.
OG006
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG0003
OG00127
OG00235
OG00326
OG0043
OG00514
OG00616
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG00123
ParticipantsOG00235
ParticipantsOG00326
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00616
Title
Measurements
OG000NA± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax).
OG001NA± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax).
OG0020.153± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.
Day 7
ParticipantsOG0001
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00324
Day 28
ParticipantsOG0003
ParticipantsOG00126
ParticipantsOG00226
ParticipantsOG00320
Participants were treated with a starting dose of oral itacitinib 200 mg QD + CS in Part 1 or had a dose reduction to oral itacitinib 200 mg QC + CS in Part 1 or Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 200 mg QD + CS and/or dose interruptions.
OG002
Parts 1 and 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 300 mg QD + CS in Part 1 or Part 1 Expansion or had a dose reduction to oral itacitinib 300 mg QC + CS in Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 400 mg QD + CS in Part 1 Expansion had a dose reduction to itacitinib 300 mg QD + CS and/or dose interruptions.
OG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG004
Part 1 Expansion: Itacitinib 100 mg BID + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.
OG005
Part 1 Expansion: Itacitinib 200 mg BID + CS
Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.
OG006
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG0003
OG00127
OG00235
OG00326
OG0043
OG00514
OG00616
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG00123
ParticipantsOG00235
ParticipantsOG00326
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00616
Title
Measurements
OG0001.0(1.0 to 1.0)
OG0012.1(0.9 to 4.8)
OG0022.1(0.8 to 5.0)
OG003
Day 7
ParticipantsOG0001
ParticipantsOG00127
ParticipantsOG00232
ParticipantsOG00326
Day 28
ParticipantsOG0003
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00321
Parts 1 and 1 Expansion: Itacitinib 200 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 200 mg QD + CS in Part 1 or had a dose reduction to oral itacitinib 200 mg QC + CS in Part 1 or Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg QD + CS in Part 1 and a starting dose of itacitinib 300 mg or 400 mg QD + CS in Part 1 Expansion had first or second dose reductions to itacitinib 200 mg QD + CS and/or dose interruptions.
OG002
Parts 1 and 1 Expansion: Itacitinib 300 mg QD + CS
Participants were treated with a starting dose of oral itacitinib 300 mg QD + CS in Part 1 or Part 1 Expansion or had a dose reduction to oral itacitinib 300 mg QC + CS in Part 1 Expansion. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease [cGVHD] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 400 mg QD + CS in Part 1 Expansion had a dose reduction to itacitinib 300 mg QD + CS and/or dose interruptions.
OG003
Part 1 Expansion: Itacitinib 400 mg QD + CS
Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG004
Part 1 Expansion: Itacitinib 100 mg BID + CS
For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.
OG005
Part 1 Expansion: Itacitinib 200 mg BID + CS
Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.
OG006
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG0003
OG00127
OG00235
OG00326
OG0043
OG00514
OG00616
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG00123
ParticipantsOG00235
ParticipantsOG00326
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00616
Title
Measurements
OG000NA± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax).
OG001NA± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax).
OG002258± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.
Day 7
ParticipantsOG0001
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00324
Day 28
ParticipantsOG0003
ParticipantsOG00126
ParticipantsOG00226
ParticipantsOG00320
0
0
0
0
0
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Month 3
Title
Measurements
OG00063.6(30.8 to 89.1)
OG00150.0(18.7 to 81.3)
Month 6
Title
Measurements
OG00036.4(10.9 to 69.2)
OG00150.0(18.7 to 81.3)
Month 12
Title
Measurements
OG00018.2(2.3 to 51.8)
OG00120.0(2.5 to 55.6)
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00139
OG00229
OG00336
Title
Denominators
Categories
Title
Measurements
OG00022.9(10.4 to 40.1)
OG00141.0(25.6 to 57.9)
OG00224.1(10.3 to 43.5)
OG00319.4(8.2 to 36.0)
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00031
OG00131
OG00225
OG00326
Title
Denominators
Categories
Title
Measurements
OG00016.0(12 to 120)
OG00116.0(12 to 86)
OG00216.0(13 to 145)
OG00316.0(13 to 88)
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00031
OG00131
OG00225
OG00326
Title
Denominators
Categories
Title
Measurements
OG000581.0(147.0 to 807.0)
OG001NA(306.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died or initiated new systemic cGVHD therapy.
OG002512.0(161.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died or initiated new systemic cGVHD therapy.
OG003197.0(103.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died or initiated new systemic cGVHD therapy.
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00139
OG00229
OG00336
Title
Denominators
Categories
Title
Measurements
OG000NA(694.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants died.
OG001NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.
OG002NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.
OG003NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00137
OG00228
OG00335
Title
Denominators
Categories
Title
Measurements
OG00025.7(12.5 to 43.3)
OG00115.4(6.2 to 32.0)
OG00210.3(2.3 to 28.2)
OG00311.1(3.2 to 26.7)
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00021
OG00127
OG00217
OG00318
Title
Denominators
Categories
Title
Measurements
OG00090.5
OG001100.0
OG002100.0
OG003100.0
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00021
OG00127
OG00217
OG00318
Title
Denominators
Categories
Title
Measurements
OG00052.4
OG00166.7
OG00247.1
OG00344.4
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00139
OG00229
OG00336
Title
Denominators
Categories
Title
Measurements
OG0005.7(0.7 to 19.2)
OG0017.7(1.6 to 20.9)
OG00213.8(3.9 to 31.7)
OG0032.8(0.1 to 14.5)
OG002
Part 1 Expansion: Itacitinib 300 mg BID + CS
Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
OG003
Part 1 Expansion: CS Monotherapy
Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Units
Counts
Participants
OG00035
OG00139
OG00229
OG00336
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.
OG001NA(NA to NA)Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.
OG002NA(NA to NA)Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.
OG003NA(NA to NA)Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.
0
0
0
0
0
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0
0
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0
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1 affected
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7 affected
39 at risk
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1 affected
39 at risk
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4 affected
39 at risk
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2 affected
39 at risk
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0 affected
39 at risk
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14 events
8 affected
39 at risk
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1 events
1 affected
39 at risk
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5 events
5 affected
39 at risk
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1 affected
39 at risk
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2 affected
39 at risk
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0 affected
39 at risk
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2 events
2 affected
39 at risk
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0 affected
39 at risk
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0 affected
39 at risk
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0 affected
39 at risk
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6 events
4 affected
39 at risk
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2 events
2 affected
39 at risk
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0 affected
39 at risk
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4 events
3 affected
39 at risk
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1 events
1 affected
39 at risk
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2 events
2 affected
39 at risk
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3 events
3 affected
39 at risk
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2 events
1 affected
39 at risk
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2 events
2 affected
39 at risk
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2 events
2 affected
39 at risk
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2 events
2 affected
39 at risk
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3 events
1 affected
39 at risk
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2 events
2 affected
39 at risk
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2 events
1 affected
39 at risk
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8 events
7 affected
39 at risk
EG0044 events4 affected29 at risk
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0 events
0 affected
39 at risk
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1 events
1 affected
39 at risk
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0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
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6 events
4 affected
39 at risk
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1 events
1 affected
39 at risk
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4 events
3 affected
39 at risk
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0 events
0 affected
39 at risk
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0 events
0 affected
39 at risk
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EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
6 events
6 affected
39 at risk
EG0041 events1 affected29 at risk
EG0059 events9 affected103 at risk
EG0064 events3 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0043 events3 affected29 at risk
EG0054 events4 affected103 at risk
EG0060 events0 affected36 at risk
3 events
3 affected
39 at risk
EG0041 events1 affected29 at risk
EG0055 events5 affected103 at risk
EG0061 events1 affected36 at risk
5 events
5 affected
39 at risk
EG0045 events4 affected29 at risk
EG00514 events13 affected103 at risk
EG0062 events2 affected36 at risk
2 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0055 events3 affected103 at risk
EG0061 events1 affected36 at risk
8 events
7 affected
39 at risk
EG00410 events9 affected29 at risk
EG00524 events22 affected103 at risk
EG0067 events7 affected36 at risk
9 events
8 affected
39 at risk
EG0043 events3 affected29 at risk
EG00514 events13 affected103 at risk
EG0063 events3 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
3 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0057 events5 affected103 at risk
EG0061 events1 affected36 at risk
6 events
4 affected
39 at risk
EG0048 events6 affected29 at risk
EG00516 events12 affected103 at risk
EG0062 events2 affected36 at risk
6 events
2 affected
39 at risk
EG0043 events1 affected29 at risk
EG00518 events8 affected103 at risk
EG0061 events1 affected36 at risk
5 events
3 affected
39 at risk
EG0044 events3 affected29 at risk
EG00517 events11 affected103 at risk
EG0061 events1 affected36 at risk
3 events
1 affected
39 at risk
EG0042 events2 affected29 at risk
EG0057 events5 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0041 events1 affected29 at risk
EG0054 events4 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0045 events2 affected29 at risk
EG0055 events2 affected103 at risk
EG0061 events1 affected36 at risk
8 events
8 affected
39 at risk
EG0045 events4 affected29 at risk
EG00516 events15 affected103 at risk
EG0065 events5 affected36 at risk
0 events
0 affected
39 at risk
EG0041 events1 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0053 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
3 events
2 affected
39 at risk
EG0041 events1 affected29 at risk
EG0054 events3 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0055 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0044 events4 affected29 at risk
EG0056 events6 affected103 at risk
EG0061 events1 affected36 at risk
4 events
4 affected
39 at risk
EG0040 events0 affected29 at risk
EG0059 events9 affected103 at risk
EG0061 events1 affected36 at risk
3 events
3 affected
39 at risk
EG0040 events0 affected29 at risk
EG0053 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
6 events
5 affected
39 at risk
EG0042 events2 affected29 at risk
EG00518 events15 affected103 at risk
EG0063 events3 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0061 events1 affected36 at risk
11 events
3 affected
39 at risk
EG0046 events3 affected29 at risk
EG00525 events11 affected103 at risk
EG0060 events0 affected36 at risk
5 events
4 affected
39 at risk
EG0040 events0 affected29 at risk
EG0055 events4 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0042 events2 affected29 at risk
EG0054 events4 affected103 at risk
EG0061 events1 affected36 at risk
5 events
5 affected
39 at risk
EG0047 events6 affected29 at risk
EG00518 events17 affected103 at risk
EG0066 events6 affected36 at risk
3 events
2 affected
39 at risk
EG0041 events1 affected29 at risk
EG0054 events3 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0053 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0041 events1 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
2 events
1 affected
39 at risk
EG0042 events2 affected29 at risk
EG0054 events3 affected103 at risk
EG0062 events2 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0061 events1 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
7 events
7 affected
39 at risk
EG00411 events9 affected29 at risk
EG00524 events22 affected103 at risk
EG0062 events2 affected36 at risk
3 events
3 affected
39 at risk
EG0041 events1 affected29 at risk
EG0055 events5 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events1 affected103 at risk
EG0061 events1 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0061 events1 affected36 at risk
1 events
1 affected
39 at risk
EG0041 events1 affected29 at risk
EG0053 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
6 events
5 affected
39 at risk
EG0046 events6 affected29 at risk
EG00518 events15 affected103 at risk
EG0064 events3 affected36 at risk
4 events
3 affected
39 at risk
EG0040 events0 affected29 at risk
EG0055 events4 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0042 events1 affected29 at risk
EG0053 events2 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0042 events1 affected29 at risk
EG0055 events4 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0061 events1 affected36 at risk
1 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
1 events
1 affected
39 at risk
EG0041 events1 affected29 at risk
EG0054 events4 affected103 at risk
EG0061 events1 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0042 events2 affected29 at risk
EG0053 events3 affected103 at risk
EG0061 events1 affected36 at risk
1 events
1 affected
39 at risk
EG0041 events1 affected29 at risk
EG0057 events6 affected103 at risk
EG0062 events2 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0061 events1 affected36 at risk
8 events
7 affected
39 at risk
EG0045 events5 affected29 at risk
EG00522 events20 affected103 at risk
EG0061 events1 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0042 events2 affected29 at risk
EG0054 events4 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0042 events2 affected29 at risk
EG0052 events2 affected103 at risk
EG0061 events1 affected36 at risk
0 events
0 affected
39 at risk
EG0041 events1 affected29 at risk
EG0051 events1 affected103 at risk
EG0061 events1 affected36 at risk
3 events
3 affected
39 at risk
EG0041 events1 affected29 at risk
EG0057 events5 affected103 at risk
EG0060 events0 affected36 at risk
2 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0054 events3 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0041 events1 affected29 at risk
EG0053 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0042 events2 affected29 at risk
EG0056 events6 affected103 at risk
EG0062 events2 affected36 at risk
1 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
2 events
1 affected
39 at risk
EG0040 events0 affected29 at risk
EG0058 events5 affected103 at risk
EG0061 events1 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
2 events
2 affected
39 at risk
EG0040 events0 affected29 at risk
EG0053 events3 affected103 at risk
EG0060 events0 affected36 at risk
0 events
0 affected
39 at risk
EG0040 events0 affected29 at risk
EG0052 events2 affected103 at risk
EG0060 events0 affected36 at risk
36.1
(20.8 to 53.8)
951
± 68.0
OG005769± 118
OG006736± 79.1
Participants
OG004
0
ParticipantsOG00514
ParticipantsOG00612
Title
Measurements
OG000191± NASD cannot be reported for a single participant.
OG0011070± 88.9
OG0021580± 125
OG0031190± 103
OG0051520± 73.0
OG0061110± 66.2
Participants
OG004
3
ParticipantsOG0058
ParticipantsOG00610
Title
Measurements
OG000486± 140
OG0011460± 67.3
OG0021290± 248
OG0031350± 72.2
OG0041350± 29.4
OG0052040± 62.6
OG0061580± 51.4
OG003135± 197
OG0057.54± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.
OG006NA± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax).
Participants
OG004
0
ParticipantsOG00514
ParticipantsOG00612
Title
Measurements
OG0000.298± NASD cannot be reported for a single participant.
OG00153.6± 218
OG00252.2± 425
OG00333.5± 118
OG005483± 175
OG006127± 177
Participants
OG004
3
ParticipantsOG0058
ParticipantsOG00610
Title
Measurements
OG00010.4± 4440
OG00168.0± 314
OG00242.2± 182
OG00329.7± 152
OG004392± 85.6
OG005460± 123
OG006195± 116
2.0
(0.0 to 5.0)
OG0052.0(1.0 to 5.0)
OG0062.4(1.0 to 5.0)
Participants
OG004
0
ParticipantsOG00514
ParticipantsOG00612
Title
Measurements
OG0001.0(1.0 to 1.0)
OG0012.1(0.0 to 5.0)
OG0022.0(1.0 to 13.4)
OG0032.0(1.0 to 5.2)
OG0051.9(0.0 to 10.7)
OG0062.0(0.9 to 5.0)
Participants
OG004
3
ParticipantsOG0058
ParticipantsOG00610
Title
Measurements
OG0004.0(1.0 to 4.8)
OG0013.1(0.8 to 12.0)
OG0022.0(0.0 to 16.9)
OG0032.1(0.9 to 5.0)
OG0042.0(2.0 to 2.2)
OG0052.3(2.0 to 5.6)
OG0062.0(1.0 to 5.0)
OG00341.2± 130
OG005640± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.
OG006NA± NAThe absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax).
Participants
OG004
0
ParticipantsOG00514
ParticipantsOG00612
Title
Measurements
OG000224± NASD cannot be reported for a single participant.