Study to Evaluate Efficacy, Safety, Tolerability, and Pha... | NCT01799889 | Trialant
NCT01799889
Sponsor
Gilead Sciences
Status
Terminated
Last Update Posted
Nov 19, 2020Actual
Enrollment
326Actual
Phase
Phase 2
Conditions
Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Diffuse Large B-cell Lymphoma
Non-FL Indolent Non-Hodgkin's Lymphoma
Follicular Lymphoma
Interventions
Entospletinib MM
Entospletinib SDD
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01799889
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-339-0102
Secondary IDs
Not provided
Brief Title
Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
Official Title
A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects With Relapsed or Refractory Hematologic Malignancies
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Nov 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor's decision to discontinue development of entospletinib.
Expanded Access Info
No
Start Date
Mar 14, 2013Actual
Primary Completion Date
Sep 14, 2017Actual
Completion Date
Jan 30, 2020Actual
First Submitted Date
Feb 13, 2013
First Submission Date that Met QC Criteria
Feb 25, 2013
First Posted Date
Feb 27, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 2, 2020
Results First Submitted that Met QC Criteria
Sep 2, 2020
Results First Posted Date
Sep 23, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 7, 2018
Certification/Extension First Submitted that Passed QC Review
Sep 7, 2018
Certification/Extension First Posted Date
Sep 12, 2018Actual
Last Update Submitted Date
Nov 2, 2020
Last Update Posted Date
Nov 19, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
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 primary objective of the study is to evaluate efficacy of entospletinib in participants with relapsed or refractory hematologic malignancies. Participants with the following relapsed or refractory hematologic malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma [MZL]).
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Diffuse Large B-cell Lymphoma
Non-FL Indolent Non-Hodgkin's Lymphoma
Follicular Lymphoma
Keywords
SYK inhibitor
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
326Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CLL, Entospletinib MM/SDD
Experimental
Participants with CLL, receive original formulation (mono-mesylate [MM]) of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib (spray dried dispersion [SDD]) 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Drug: Entospletinib MM
Drug: Entospletinib SDD
FL, Entospletinib MM/SDD
Experimental
Participants with FL, receive original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Drug: Entospletinib MM
Drug: Entospletinib SDD
DLBCL, Entospletinib MM/SDD
Experimental
Participants with DLBCL, receive original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Drug: Entospletinib MM
Drug: Entospletinib SDD
MCL, Entospletinib MM/SDD
Experimental
Participants with MCL, receive original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Entospletinib MM
Drug
Entospletinib MM tablet administered orally
CLL, Entospletinib MM/SDD
DLBCL, Entospletinib MM/SDD
FL, Entospletinib MM/SDD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16
PFS rate was assessed by Independent Review Committee (IRC) and defined per standardized criteria (2007 Cheson criteria) (for NHL) and International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal immunoglobulin M (IgM) concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using Kaplan-Meier (KM) estimates.
Week 16
PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24
PFS rate was assessed by IRC and defined per standardized criteria (2007 Cheson criteria) (for NHL) and IWCLL criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria (2007 Cheson criteria) as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal IgM concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using KM estimates.
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
A treatment-emergent Adverse Event (AE) was defined as an AE that occurs in the period from the first dose of study treatment to 30 days after the last dose of study treatment or leads to discontinuation of study treatment. Participants were assessed for AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization
For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol
Prior treatment for lymphoid malignancy requiring treatment for progressive disease
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug
Karnofsky performance status of ≥ 60
Life expectancy of at least 3 months
Key Exclusion Criteria:
Known histological transformation from iNHL or CLL to an aggressive form of non-Hodgkin lymphoma (ie, Richter transformation) except if the CLL participant is enrolling in the BCR previously treated cohort
Known active central nervous system or leptomeningeal lymphoma
Presence of known intermediate- or high-grade myelodysplastic syndrome
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
Ongoing liver injury
Ongoing or recent hepatic encephalopathy
Ongoing drug-induced pneumonitis
Ongoing inflammatory bowel disease
Ongoing alcohol or drug addiction
Pregnancy or breastfeeding
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Ongoing immunosuppressive therapy
Concurrent participation in an investigational drug trial with therapeutic intent
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Sharman J, Hawkins M, Kolibaba K, Boxer M, Klein L, Wu M, Hu J, Abella S, Yasenchak C. An open-label phase 2 trial of entospletinib (GS-9973), a selective spleen tyrosine kinase inhibitor, in chronic lymphocytic leukemia. Blood. 2015 Apr 9;125(15):2336-43. doi: 10.1182/blood-2014-08-595934. Epub 2015 Feb 18.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
444 participants were screened.
Recruitment Details
Participants were enrolled at study sites in United States and Canada. The first participant was screened on 14 March 2013. The last study visit occurred on 30 January 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CLL: Entospletinib MM/SDD
Participants with chronic lymphocytic leukemia (CLL), received original formulation (mono-mesylate [MM]) of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib (spray dried dispersion [SDD]) 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Mar 31, 2017
Jul 30, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Entospletinib MM
Drug: Entospletinib SDD
non-FL iNHL, Entospletinib MM/SDD
Experimental
Participants with non-FL iNHL (ie, participants with LPL/WM, SLL, or MZL), receive original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL, who are prior B-cell receptor (BCR) inhibitor naive, receive new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL, who are prior BCR inhibitor naive, receive new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL, who are prior BCR inhibitor naive, receive new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who are exposed to Bruton tyrosine kinase (BTK) inhibitor, receive new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who are exposed to phosphatidylinositol 3-kinase (PI3K) inhibitor, receive new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL, who transform to Richters or Richters-like syndrome and are exposed to BTK inhibitor, receive new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
Participants with CLL, who transform to Richters or Richters-like syndrome and are exposed to PI3K inhibitor, receive new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
First dose date up to the last dose date plus 30 days (maximum: 78.4 months)
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Hematology toxicity at any time postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test.
First dose date up to the last dose date plus 30 days (maximum: 78.4 months)
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Serum chemistry toxicity at anytime postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase
First dose date up to the last dose date plus 30 days (maximum: 78.4 months)
Objective Response Rate (ORR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
ORR: percentage of participants with complete response (CR) or partial response (PR) (or very good PR [VGPR] or minor response [MR] for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in sum of products (SPD) of the longest diameters of all index lesions, no new lesions; VGPR: >90% decrease from baseline (DFB) in IgM, and other criteria for CR met; MR: ≥25% but <50% DFB in IgM, no increase from baseline (IFB) in SPD of lesions, no new lesions. Per IWCLL, CR: lymphocytes (Ly) <4*10^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, absolute neutrophil count (ANC) >1.5*10^9/L, platelets ≥100*10^9/L, hemoglobin (Hb) >110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC >1500/μL, platelets ≥100,000/µL, Hb >11 g/dL.
From first dose date until first occurrence of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years)
Duration of Response (DOR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
DOR was defined as the interval from first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to earlier of first documentation of definitive disease progression or death from any cause. Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in SPD of longest diameters of all index lesions, no new lesions; VGPR: >90% DFB in IgM, and other criteria for CR met; MR: ≥25% but <50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly <4*10^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC >1.5*10^9/L, platelets ≥100*10^9/L, Hb >110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC>1500/μL, platelets ≥100,000/µL, Hb >11 g/dL. Disease progression: as defined in Outcome measure 1. DOR was analyzed using KM estimates.
From the date of first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to disease progression or death from any cause (up to approximately 7 years)
Time to Response (TTR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
TTR was defined as the interval from the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥ 50% reduction in SPD of the longest diameters of all index lesions, no new lesions; VGPR: >90% DFB in IgM, and other criteria for CR met; MR: ≥25% but <50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly <4*10^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC >1.5*10^9/L, platelets ≥100*10^9/L, Hb >110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC >1500/μL, platelets ≥100,000/µL, Hb >11 g/dL.
From the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years)
Tucson
Arizona
85710
United States
City of Hope National Medical Center
Duarte
California
91010
United States
Sharp Memorial Hospital
San Diego
California
92123
United States
Rocky Mountain Cancer Centers, LLP
Boulder
Colorado
80303
United States
Kaiser Permanente of Colorado
Denver
Colorado
80218
United States
Cancer Center of Central Connecticut
Southington
Connecticut
06489
United States
Florida Cancer - Colonial
Fort Myers
Florida
33905
United States
Memorial Cancer Institute
Hollywood
Florida
33021
United States
Ocala Oncology Center
Ocala
Florida
34471
United States
Northside Hospital
Atlanta
Georgia
30341
United States
Gwinnett Hospital System Dba The Center for Cancer Care
Lawrenceville
Georgia
30046
United States
Northwest Georgia Oncology Center
Marietta
Georgia
30060
United States
University of Chicago
Chicago
Illinois
60637
United States
Illinois Cancer Specialists
Niles
Illinois
60714
United States
Indiana University Simon Cancer Center
Indianapolis
Indiana
46202
United States
Hematology Oncology Clinic, PLLC
Baton Rouge
Louisiana
70809
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Minnesota Oncology Hematology, PA
Minneapolis
Minnesota
55404
United States
Hattiesburg Clinic
Hattiesburg
Mississippi
39401
United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha
Nebraska
68130
United States
One Medical Center Drive
Lebanon
New Hampshire
03756
United States
Summit Medical Group, P.A.
Florham Park
New Jersey
07932
United States
Clinical Research Alliance
New York
New York
10021
United States
University of North Carolina
Chapel Hill
North Carolina
27599
United States
Gabrail Cancer Center Research
Canton
Ohio
44718
United States
Oncology Hematology Care
Cincinnati
Ohio
45242
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Ohio State University Comprehensive Cancer Center
Columbus
Ohio
43210
United States
Williamette Valley Cancer Center and Research Institute
Springfield
Oregon
97477
United States
Prairie Lakes Health Care System, Inc.
Watertown
South Dakota
57201
United States
Jones Clinic PC
Germantown
Tennessee
38138
United States
Tennessee Oncology, PLLC
Nashville
Tennessee
37203
United States
Texas Oncology-Austin Midtown
Austin
Texas
78705
United States
Texas Oncology-Medical City Dallas
Dallas
Texas
75230
United States
Center for Cancer and Blood Disorders
Fort Worth
Texas
76104
United States
Cancer Care Network of South Texas
San Antonio
Texas
78217
United States
Cancer Care Center of South Texas
San Antonio
Texas
78229
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Virginia Cancer Institute
Richmond
Virginia
23226
United States
Columbia Basin Hematology and Oncology
Kennewick
Washington
99336
United States
University of Washington
Seattle
Washington
98109
United States
Northwest Cancer Specialists, PC
Vancouver
Washington
98684
United States
Yakima Valley Memorial Hospital North Star Lodge
Yakima
Washington
98902
United States
Royal Victoria Regional Health Centre
Barrie
Ontario
L4M 6M2
Canada
Sir Mortimer B. Davis-Jewish General Hospital
Montreal
Quebec
H3T 1E2
Canada
FG001
FL: Entospletinib MM/SDD
Participants with follicular lymphoma (FL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
FG002
DLBCL: Entospletinib MM/SDD
Participants with diffuse large B-cell lymphoma (DLBCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
FG003
MCL: Entospletinib MM/SDD
Participants with mantle cell lymphoma (MCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
FG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with non-FL indolent non-Hodgkin lymphomas (iNHL), (ie, participants with lymphoplasmacytoid lymphoma/ waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma [MZL]), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior B-cell receptor (BCR) inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to Bruton tyrosine kinase (BTK) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to phosphatidylinositol 3-kinase (PI3K) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
FG00041 subjects
FG00141 subjects
FG00244 subjects
FG00339 subjects
FG00449 subjects
FG00520 subjects
FG00621 subjects
FG00720 subjects
FG00833 subjects
FG0098 subjects
FG0107 subjects
FG0113 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00041 subjects
FG00141 subjects
FG00244 subjects
FG00339 subjects
FG00449 subjects
FG00520 subjects
FG00621 subjects
FG00720 subjects
FG00833 subjects
FG0098 subjects
FG0107 subjects
FG0113 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0014 subjects
FG0025 subjects
FG0031 subjects
FG00411 subjects
FG0051 subjects
FG0065 subjects
FG0072 subjects
FG0083 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
Death
FG0001 subjects
FG0010 subjects
FG0025 subjects
FG0033 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0003 subjects
FG0012 subjects
FG0024 subjects
FG0034 subjects
FG004
Progressive Disease
FG00030 subjects
FG00126 subjects
FG00225 subjects
FG00330 subjects
FG004
Specified Criteria for Withdrawal
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Terminated By Sponsor
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0016 subjects
FG0024 subjects
FG0030 subjects
FG004
Non-Compliance With Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Full Analysis Set included all enrolled participants who took at least one dose of study drug with treatment group designated according to the planned treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
BG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
BG002
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
BG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
BG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00041
BG00141
BG00243
BG00339
BG00449
BG00519
BG00621
BG00720
BG00833
BG0098
BG0106
BG0113
BG012323
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
BG00073± 9.6
BG00166± 11.7
BG00267± 14.8
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00121
BG002
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of Ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0000
BG0014
Race/Ethnicity, Customized
Not Permitted=local regulators did not allow collection of Race information.
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
Asian
BG0000
BG0011
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
Title
Measurements
BG0000
BG0010
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
Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16
PFS rate was assessed by Independent Review Committee (IRC) and defined per standardized criteria (2007 Cheson criteria) (for NHL) and International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal immunoglobulin M (IgM) concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using Kaplan-Meier (KM) estimates.
The Full Analysis Set included all enrolled participants who took at least one dose of study drug with treatment group designated according to the planned treatment. Only participants with CLL after BCR target therapy (including CLL non-Richters, and CLL Richters participants), SDD, MCL, and DLBCL were analyzed for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG001
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00043
OG00139
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.6(0.3 to 15.2)
OG00163.9(45 to 77.8)
OG00264(43.2 to 78.9)
OG003
Primary
PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24
PFS rate was assessed by IRC and defined per standardized criteria (2007 Cheson criteria) (for NHL) and IWCLL criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria (2007 Cheson criteria) as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal IgM concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using KM estimates.
Participants in the full analysis set were analyzed. Only participants with CLL (including CLL, prior BCR inhibitor naive participants), FL, and non-FL iNHL were analyzed for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Secondary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
A treatment-emergent Adverse Event (AE) was defined as an AE that occurs in the period from the first dose of study treatment to 30 days after the last dose of study treatment or leads to discontinuation of study treatment. Participants were assessed for AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
Posted
Number
percentage of participants
First dose date up to the last dose date plus 30 days (maximum: 78.4 months)
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Secondary
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Hematology toxicity at any time postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test.
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to the last dose date plus 30 days (maximum: 78.4 months)
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG002
DLBCL: Entospletinib MM/SDD
Secondary
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Serum chemistry toxicity at anytime postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to the last dose date plus 30 days (maximum: 78.4 months)
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG002
DLBCL: Entospletinib MM/SDD
Secondary
Objective Response Rate (ORR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
ORR: percentage of participants with complete response (CR) or partial response (PR) (or very good PR [VGPR] or minor response [MR] for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in sum of products (SPD) of the longest diameters of all index lesions, no new lesions; VGPR: >90% decrease from baseline (DFB) in IgM, and other criteria for CR met; MR: ≥25% but <50% DFB in IgM, no increase from baseline (IFB) in SPD of lesions, no new lesions. Per IWCLL, CR: lymphocytes (Ly) <4*10^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, absolute neutrophil count (ANC) >1.5*10^9/L, platelets ≥100*10^9/L, hemoglobin (Hb) >110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC >1500/μL, platelets ≥100,000/µL, Hb >11 g/dL.
Participants in the Full Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose date until first occurrence of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years)
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Secondary
Duration of Response (DOR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
DOR was defined as the interval from first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to earlier of first documentation of definitive disease progression or death from any cause. Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in SPD of longest diameters of all index lesions, no new lesions; VGPR: >90% DFB in IgM, and other criteria for CR met; MR: ≥25% but <50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly <4*10^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC >1.5*10^9/L, platelets ≥100*10^9/L, Hb >110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC>1500/μL, platelets ≥100,000/µL, Hb >11 g/dL. Disease progression: as defined in Outcome measure 1. DOR was analyzed using KM estimates.
Participants in the Full Analysis Set with objective response were analyzed.
Posted
Median
95% Confidence Interval
months
From the date of first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to disease progression or death from any cause (up to approximately 7 years)
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Secondary
Time to Response (TTR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
TTR was defined as the interval from the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥ 50% reduction in SPD of the longest diameters of all index lesions, no new lesions; VGPR: >90% DFB in IgM, and other criteria for CR met; MR: ≥25% but <50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly <4*10^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC >1.5*10^9/L, platelets ≥100*10^9/L, Hb >110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC >1500/μL, platelets ≥100,000/µL, Hb >11 g/dL.
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
months
From the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years)
ID
Title
Description
OG000
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Time Frame
Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
Description
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
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
CLL: Entospletinib MM/SDD
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
4
41
17
41
40
41
EG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
3
41
9
41
39
41
EG002
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
13
43
16
43
42
43
EG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
6
39
16
39
38
39
EG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
1
3
2
3
2
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG0030 affected39 at risk
EG0042 affected49 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected20 at risk
EG0083 affected33 at risk
EG0090 affected8 at risk
EG0100 affected6 at risk
EG0110 affected3 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Bandaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0022 affected43 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Gait inability
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Generalised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Abscess soft tissue
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
H1n1 influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Haematoma infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0011 affected41 at risk
EG0023 affected43 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Rotavirus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Salivary gland cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected41 at risk
EG0022 affected43 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG00012 affected41 at risk
EG0017 affected41 at risk
EG00211 affected43 at risk
EG0036 affected39 at risk
EG0049 affected49 at risk
EG0056 affected19 at risk
EG0067 affected21 at risk
EG0073 affected20 at risk
EG00813 affected33 at risk
EG0091 affected8 at risk
EG0102 affected6 at risk
EG0110 affected3 at risk
Haemolysis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypoglobulinaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0022 affected43 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0014 affected41 at risk
EG0023 affected43 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0016 affected41 at risk
EG0023 affected43 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0011 affected41 at risk
EG0022 affected43 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Excessive cerumen production
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Eye pain
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Optic nerve disorder
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Photophobia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0023 affected43 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0013 affected41 at risk
EG0022 affected43 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0015 affected41 at risk
EG0027 affected43 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0014 affected41 at risk
EG0020 affected43 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00010 affected41 at risk
EG0018 affected41 at risk
EG00212 affected43 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00024 affected41 at risk
EG00116 affected41 at risk
EG00211 affected43 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0016 affected41 at risk
EG0021 affected43 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0015 affected41 at risk
EG0023 affected43 at risk
EG003
Gingival discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00019 affected41 at risk
EG00121 affected41 at risk
EG00218 affected43 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Oral mucosal exfoliation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Palatal oedema
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Parotid gland enlargement
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Tongue coated
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG00110 affected41 at risk
EG0026 affected43 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0013 affected41 at risk
EG0023 affected43 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0012 affected41 at risk
EG0023 affected43 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0017 affected41 at risk
EG0022 affected43 at risk
EG003
Complication associated with device
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG00026 affected41 at risk
EG00122 affected41 at risk
EG00218 affected43 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Generalised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Injection site bruising
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Nodule
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG00010 affected41 at risk
EG0013 affected41 at risk
EG0029 affected43 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0013 affected41 at risk
EG0021 affected43 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG00012 affected41 at risk
EG0019 affected41 at risk
EG0024 affected43 at risk
EG003
Swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tenderness
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Thirst
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Alpha haemolytic streptococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Impetigo
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0007 affected41 at risk
EG0013 affected41 at risk
EG0022 affected43 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00014 affected41 at risk
EG0017 affected41 at risk
EG0021 affected43 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0008 affected41 at risk
EG0015 affected41 at risk
EG0025 affected43 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0015 affected41 at risk
EG0020 affected43 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Incision site haemorrhage
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0017 affected41 at risk
EG0024 affected43 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0017 affected41 at risk
EG0026 affected43 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0015 affected41 at risk
EG0023 affected43 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0019 affected41 at risk
EG0025 affected43 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0015 affected41 at risk
EG0024 affected43 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Heart rate increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
High density lipoprotein decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Lymph node palpable
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0013 affected41 at risk
EG0021 affected43 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0022 affected43 at risk
EG003
Protein total decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0014 affected41 at risk
EG0024 affected43 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
White blood cell count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG00012 affected41 at risk
EG0019 affected41 at risk
EG00216 affected43 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0014 affected41 at risk
EG0028 affected43 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0024 affected43 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0013 affected41 at risk
EG0020 affected43 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0013 affected41 at risk
EG0022 affected43 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0013 affected41 at risk
EG0021 affected43 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0013 affected41 at risk
EG0025 affected43 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0012 affected41 at risk
EG0024 affected43 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0010 affected41 at risk
EG0025 affected43 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG00010 affected41 at risk
EG0016 affected41 at risk
EG0021 affected43 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0012 affected41 at risk
EG0025 affected43 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0012 affected41 at risk
EG0023 affected43 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0013 affected41 at risk
EG0020 affected43 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0014 affected41 at risk
EG0022 affected43 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0005 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00013 affected41 at risk
EG0019 affected41 at risk
EG0026 affected43 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00014 affected41 at risk
EG0019 affected41 at risk
EG0024 affected43 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0022 affected43 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0022 affected43 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Tremor
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0013 affected41 at risk
EG0024 affected43 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0013 affected41 at risk
EG0026 affected43 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0013 affected41 at risk
EG0022 affected43 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0007 affected41 at risk
EG0014 affected41 at risk
EG0029 affected43 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0021 affected43 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0013 affected41 at risk
EG0020 affected43 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG00012 affected41 at risk
EG0018 affected41 at risk
EG0029 affected43 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0007 affected41 at risk
EG0013 affected41 at risk
EG00212 affected43 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected41 at risk
EG0022 affected43 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0013 affected41 at risk
EG0020 affected43 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0014 affected41 at risk
EG0020 affected43 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0023 affected43 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0013 affected41 at risk
EG0020 affected43 at risk
EG003
Pulmonary cavitation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0023 affected43 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Tonsillar disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0012 affected41 at risk
EG0020 affected43 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0011 affected41 at risk
EG0021 affected43 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected41 at risk
EG0014 affected41 at risk
EG0021 affected43 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0017 affected41 at risk
EG0024 affected43 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected41 at risk
EG0017 affected41 at risk
EG0022 affected43 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0022 affected43 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0014 affected41 at risk
EG0021 affected43 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0010 affected41 at risk
EG0021 affected43 at risk
EG003
Transient acantholytic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Hot flush
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected41 at risk
EG0011 affected41 at risk
EG0020 affected43 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected41 at risk
EG0012 affected41 at risk
EG0023 affected43 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected41 at risk
EG0020 affected43 at risk
EG003
Study was terminated prematurely due to sponsor's decision to discontinue development of entospletinib.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
8
OG0046
OG0053
100
(100 to 100)
OG00420(0.8 to 58.2)
OG00550(0.6 to 91)
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG002
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00041
OG00141
OG00249
OG00319
OG00421
OG00520
Title
Denominators
Categories
Title
Measurements
OG00066.9(48 to 80.2)
OG00151.5(32.8 to 67.4)
OG00263.5(45.3 to 77.1)
OG00364.2(33.4 to 83.6)
OG00481.6(51.6 to 93.9)
OG00584.2(58.7 to 94.6)
OG002
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00041
OG00141
OG00243
OG00339
OG00449
OG00519
OG00621
OG00720
OG00833
OG0098
OG0106
OG0113
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG00297.7
OG00397.4
OG004100.0
OG005100.0
OG00695.2
OG007100.0
OG008100.0
OG009100.0
OG010100.0
OG011100.0
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00041
OG00141
OG00243
OG00339
OG00449
OG00519
OG00621
OG00720
OG00833
OG0098
OG0106
OG0113
Title
Denominators
Categories
Grade 3 ANC Decrease
Title
Measurements
OG00014.6
OG00112.2
OG0022.3
OG0032.6
OG0046.1
OG00515.8
OG0069.5
OG00725.0
OG00812.1
OG00925.0
OG01033.3
OG0110
Grade 4 ANC Decrease
Title
Measurements
OG00022.0
OG0014.9
OG0024.7
OG003
Grade 3 Anemia
Title
Measurements
OG00014.6
OG0019.8
OG00214.0
OG003
Grade 4 Anemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hb Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Hb Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Leukocytosis
Title
Measurements
OG00034.1
OG0012.4
OG0020
OG003
Grade 4 Leukocytosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 WBC Decrease
Title
Measurements
OG0002.4
OG00112.2
OG0020
OG003
Grade 4 WBC Decrease
Title
Measurements
OG0000
OG0010
OG0024.7
OG003
Grade 3 Lymphocyte Count Decrease
Title
Measurements
OG0000
OG00117.1
OG00248.8
OG003
Grade 4 Lymphocyte Count Decrease
Title
Measurements
OG0002.4
OG0012.4
OG0029.3
OG003
Grade 3 Lymphocyte Count Increase
Title
Measurements
OG00085.4
OG0019.8
OG0020
OG003
Grade 4 Lymphocyte Count Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Neutrophils Decrease
Title
Measurements
OG00014.6
OG00112.2
OG0022.3
OG003
Grade 4 Neutrophils Decrease
Title
Measurements
OG00019.5
OG0010
OG0022.3
OG003
Grade 3 Platelet Count Decrease
Title
Measurements
OG0007.3
OG0012.4
OG0022.3
OG003
Grade 4 Platelet Count Decrease
Title
Measurements
OG0007.3
OG0014.9
OG0020
OG003
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00041
OG00141
OG00243
OG00339
OG00449
OG00519
OG00621
OG00720
OG00833
OG0098
OG0106
OG0113
Title
Denominators
Categories
Grade 3 ALT Increase
Title
Measurements
OG0007.3
OG0019.8
OG0029.3
OG00315.4
OG0048.2
OG0050
OG0064.8
OG0075.0
OG0083.0
OG0090
OG0100
OG0110
Grade 4 ALT Increase
Title
Measurements
OG0002.4
OG0019.8
OG0022.3
OG003
Grade 3 Hypoalbuminemia
Title
Measurements
OG0000
OG0012.4
OG0020
OG003
Grade 4 Hypoalbuminemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 ALP Increase
Title
Measurements
OG0000
OG0012.4
OG0020
OG003
Grade 4 ALP Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 AST Increase
Title
Measurements
OG0007.3
OG00112.2
OG0027.0
OG003
Grade 4 AST Increase
Title
Measurements
OG0000
OG0014.9
OG0022.3
OG003
Grade 3 Blood Bilirubin Increase
Title
Measurements
OG0007.3
OG0014.9
OG0024.7
OG003
Grade 4 Blood Bilirubin Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Creatine Kinase Decrease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Creatine Kinase Decrease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Creatine Kinase Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Creatine Kinase Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Creatinine
Title
Measurements
OG0000
OG0017.3
OG0022.3
OG003
Grade 4 Creatinine
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Creatinine Clearance Decrease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Creatinine Clearance Decrease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Creatinine Clearance Increase
Title
Measurements
OG0009.8
OG00117.1
OG0022.3
OG003
Grade 4 Creatinine Clearance Increase
Title
Measurements
OG0000
OG0012.4
OG0022.3
OG003
Grade 3 Direct Bilirubin Decrease
Title
Measurements
OG0000
OG0012.4
OG0024.7
OG003
Grade 4 Direct Bilirubin Decrease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Direct Bilirubin Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Direct Bilirubin Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hyperglycemia
Title
Measurements
OG0009.8
OG0019.8
OG0024.7
OG003
Grade 4 Hyperglycemia
Title
Measurements
OG0000
OG0012.4
OG0020
OG003
Grade 3 Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypercalcemia
Title
Measurements
OG0000
OG0012.4
OG0020
OG003
Grade 4 Hypercalcemia
Title
Measurements
OG0000
OG0012.4
OG0022.3
OG003
Grade 3 Hypocalcemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Hypocalcemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Indirect Bilirubin Decrease
Title
Measurements
OG0004.9
OG0012.4
OG0020
OG003
Grade 4 Indirect Bilirubin Decrease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Indirect Bilirubin Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Indirect Bilirubin Increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypermagnesemia
Title
Measurements
OG0002.4
OG0012.4
OG0022.3
OG003
Grade 4 Hypermagnesemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypomagnesemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Hypomagnesemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypophosphatemia
Title
Measurements
OG00014.6
OG0014.9
OG0020
OG003
Grade 4 Hypophosphatemia
Title
Measurements
OG0002.4
OG0010
OG0020
OG003
Grade 3 Hyperkalemia
Title
Measurements
OG0004.9
OG0010
OG0020
OG003
Grade 4 Hyperkalemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypokalemia
Title
Measurements
OG0007.3
OG0019.8
OG0024.7
OG003
Grade 4 Hypokalemia
Title
Measurements
OG0002.4
OG0010
OG0020
OG003
Grade 3 Hypernatremia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Hypernatremia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hyponatremia
Title
Measurements
OG00012.2
OG0012.4
OG00211.6
OG003
Grade 4 Hyponatremia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG002
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00041
OG00141
OG00243
OG00339
OG00449
OG00519
OG00621
OG00720
OG00833
OG0098
OG0106
OG0113
Title
Denominators
Categories
Title
Measurements
OG00053.7(37.4 to 69.3)
OG00117.1(7.2 to 32.1)
OG0020(0.0 to 8.2)
OG00317.9(7.5 to 33.5)
OG00436.7(23.4 to 51.7)
OG00526.3(9.1 to 51.2)
OG00638.1(18.1 to 61.6)
OG00760.0(36.1 to 80.9)
OG00824.2(11.1 to 42.3)
OG00975.0(34.9 to 96.8)
OG01033.3(4.3 to 77.7)
OG0110(0.0 to 70.8)
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG002
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00022
OG0017
OG0020
OG0037
OG00418
OG0055
OG0068
OG00712
OG0088
OG0096
OG0102
OG0110
Title
Denominators
Categories
Title
Measurements
OG00022(12.7 to 36.7)
OG0017.6(2.2 to NA)Due to less number of participants with an event, upper limit of 95% CI could not be estimable.
OG0037.5(1.9 to 14.3)
OG00419(9 to 56)
OG00526.9(1.7 to 42.3)
OG00614.9(1.2 to 41.3)
OG00717.(9 to 39.2)
OG0088.1(1.2 to NA)Due to less number of participants with an event, upper limit of 95% CI could not be estimable.
OG00911.3(3.4 to NA)Due to less number of participants with an event, upper limit of 95% CI could not be estimable.
OG0102.7(1.6 to 3.8)
OG001
FL: Entospletinib MM/SDD
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG002
DLBCL: Entospletinib MM/SDD
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG003
MCL: Entospletinib MM/SDD
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
OG004
Non-FL iNHL: Entospletinib MM/SDD
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.