Ibrutinib in Combination With Lenalidomide and Rituximab... | NCT02077166 | Trialant
NCT02077166
Sponsor
Pharmacyclics LLC.
Status
Completed
Last Update Posted
Feb 4, 2022Actual
Enrollment
138Actual
Phase
Phase 1Phase 2
Conditions
Relapsed Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Interventions
Ibrutinib
Lenalidomide
Rituximab
Countries
United States
Belgium
Germany
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02077166
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PCYC-1123-CA
Secondary IDs
ID
Type
Description
Link
2013-004341-17
EudraCT Number
Brief Title
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official Title
A Multicenter Open-Label Phase 1b/2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acronym
Not provided
Organization
Pharmacyclics LLC.INDUSTRY
Status Module
Record Verification Date
Jan 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 13, 2014Actual
Primary Completion Date
Dec 17, 2020Actual
Completion Date
Dec 17, 2020Actual
First Submitted Date
Feb 10, 2014
First Submission Date that Met QC Criteria
Feb 28, 2014
First Posted Date
Mar 4, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 30, 2021
Results First Submitted that Met QC Criteria
Jan 6, 2022
Results First Posted Date
Feb 4, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 6, 2022
Last Update Posted Date
Feb 4, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Pharmacyclics LLC.INDUSTRY
Collaborators
Name
Class
Janssen Research & Development, LLC
INDUSTRY
Celgene Corporation
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
Detailed Description
Phase 1b: In the dose escalation portion of the study, various cohorts with escalating doses of lenalidomide may be explored, using the 3+3+3 principle for dose determination.
Phase 2: This will be conducted as an international, multicenter, open-label study. Eligible subjects will receive ibrutinib, lenalidomide and rituximab.
Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
The dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A Dose Level Review Committee evaluated safety data following completion of each dose observation period of the Phase 1b portion.
Estimated median time on study in Phase 1b was 59.6 months.
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization > 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events were those that were considered possibly related or related to study drug per investigator's judgment. Events were graded per the national Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03: Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening; grade 5=death.
From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0.
Phase 2: Overall Response Rate (ORR)
The ORR was defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR), according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014), as assessed by the investigator in response-evaluable population. The 95% confidence interval (CI) was calculated using the exact method.
Secondary Outcomes
Measure
Description
Time Frame
Phase 1b: ORR
The ORR was defined as the percentage of participants who achieve either a PR or CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. The 95% CI was calculated using the exact method.
Must have previously received first line treatment regimen
Must be ineligible for high dose therapy/ stem cell transplantation
Measurable disease sites on computed tomography (CT) scan (>1.5 cm in longest dimension)
prothrombin time/international normalized ratio (PT/INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time [aPTT]) <1.5 x ULN
Men and women ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) < 2
Adequate hepatic and renal function
Adequate hematologic function
Exclusion Criteria:
Medically apparent central nervous system lymphoma or leptomeningeal disease
History of allogeneic stem-cell (or other organ) transplantation
Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
Radio- or toxin-immunoconjugates within 10 weeks
Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
Ramchandren R, Johnson P, Ghosh N, Ruan J, Ardeshna KM, Johnson R, Verhoef G, Cunningham D, de Vos S, Kassam S, Fayad L, Radford J, Bailly S, Offner F, Morgan D, Munoz J, Ping J, Szafer-Glusman E, Eckert K, Neuenburg JK, Goy A. The iR2 regimen (ibrutinib plus lenalidomide and rituximab) for relapsed/refractory DLBCL: A multicentre, non-randomised, open-label phase 2 study. EClinicalMedicine. 2022 Dec 26;56:101779. doi: 10.1016/j.eclinm.2022.101779. eCollection 2023 Feb.
Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.
In the Phase 1b portion of this study, different dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema.
A total of 138 participants enrolled in the study; however, 4 participants exited the study without receiving any treatment, and are not presented in any data table.
Recruitment Details
All participants had relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In the Phase 1b portion of the study, all subtypes of DLBCL and participants with transformed disease were enrolled. In the Phase 2 portion of the study, only participants with non-germinal-center B-cell-like (non-GCB) DLBCL were enrolled.
Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jun 1, 2016
Nov 30, 2021
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
Non-Randomized
Intervention Model
Sequential 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
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Experimental
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Experimental
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Estimated median time on study in Phase 2 was 35.0 months.
Estimated median time on study in Phase 1b was 59.6 months.
Phase 1b: Complete Response (CR) Rate
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease, as assessed by the Investigator.
Estimated median time on Phase 1b study was 59.6 months.
Phase 2: CR Rate
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (see Cheson, 2014 for detailed criteria) in response-evaluable population, as assessed by the Investigator.
Estimated median time on study in Phase 2 was 35.0 months.
Phase 2: Duration of Response (DOR)
DOR is defined as the time from the date of the first documented response (CR or PR) to the first documented evidence of disease progression (PD) according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause. For participants who had achieved an overall response but did not die or progress at the time of analysis, DOR was censored on the date of the last adequate post-baseline disease assessment, or on the date of the first occurrence of response (CR or PR) if there was no disease assessment afterwards. 2-sided 95% CI is estimated by Kaplan-Meier method.
Estimated median time on study in Phase 2 was 35.0 months.
Phase 2: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to confirmed PD according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause, whichever occurred first. For participants without disease progression or death, PFS data was censored at the date of the last tumor assessment. 2 sided 95% CI is estimated by Kaplan-Meier method.
Estimated median time on study in Phase 2 was 35.0 months.
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of the first dose of study drug to the date of death due to any cause. For participants not known to have died at or prior to the database lock date, OS data was censored at the date last known alive. Participants who withdrew consent prior to study closure were censored on the date of the consent withdrawal. 2-sided 95% CI was estimated by Kaplan-Meier method.
Estimated median time on study in Phase 2 was 35.0 months.
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization > 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events were those that were considered possibly related or related to study drug per investigator's judgment. Events were graded per the national Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03: Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening; grade 5=death.
From first dose of study drug up to 30 days after last dose of study drug. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
Gilbert
Arizona
85234
United States
Cedar Sinai Medical Center
Los Angeles
California
90048
United States
UCLA Medical Center
Los Angeles
California
90095
United States
University of Florida
Gainesville
Florida
32610
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
University of Iowa
Iowa City
Iowa
52242
United States
Tulane Medical Center
New Orleans
Louisiana
70112
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Comprehensive Cancer Center of Nevada
Las Vegas
Nevada
89169
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
Summit Medical Group
Morristown
New Jersey
07960
United States
Weill Cornell Medical Center
New York
New York
10065
United States
Levine Cancer Institute
Charlotte
North Carolina
28204
United States
University of Cincinnati Health Barrett Center
Cincinnati
Ohio
45267
United States
Mid-Ohio Oncology/ Hematology
Columbus
Ohio
43219
United States
University of TN Medical Center
Knoxville
Tennessee
37920
United States
Vanderbilt Ingram Cancer Center
Nashville
Tennessee
37232
United States
Baylor Charles Sammons Cancer Center
Dallas
Texas
75246
United States
The University of Texas, MD Anderson Cancer Center
Houston
Texas
77030
United States
Medical Oncology Associates, PS
Spokane
Washington
99208
United States
Northwest Medical Specialities, PLLC
Tacoma
Washington
98405
United States
Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg
Antwerp
2060
Belgium
CHU Brugmann
Brussels
Belgium
Cliniques Universitaires Saint-Luc
Brussels
Belgium
Universitair Ziekenhuis Gent
Ghent
Belgium
UZ Leuven
Leuven
Belgium
Universiaetsklinikum Ulm
Ulm
Baden-Wurttemberg
89081
Germany
Klinikum der Universitaet Muenchen - Campus Grosshadern
Munich
Bavaria
81377
Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen, III. Medizinische Klinik und Polyklinik
Munich
Bavaria
81675
Germany
Universitaetsklinikum Wuerzburg, Medizinische Klinik und Poliklinik II
Würzburg
Bavaria
97080
Germany
University Hospitals Birmingham NHS Foundation Trust
Birmingham
United Kingdom
University Hospital of Wales
Cardiff
United Kingdom
Northwick Park Hospital
Harrow
United Kingdom
The Leeds Teaching Hospitals
Leeds
United Kingdom
Kings College Hospital
London
United Kingdom
University College London Hospitals
London
United Kingdom
The Christie NHS Foundation Trust
Manchester
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton
United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton
United Kingdom
Derived
Goy A, Ramchandren R, Ghosh N, Munoz J, Morgan DS, Dang NH, Knapp M, Delioukina M, Kingsley E, Ping J, Beaupre DM, Neuenburg JK, Ruan J. Ibrutinib plus lenalidomide and rituximab has promising activity in relapsed/refractory non-germinal center B-cell-like DLBCL. Blood. 2019 Sep 26;134(13):1024-1036. doi: 10.1182/blood.2018891598. Epub 2019 Jul 22.
De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
FG005
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
FG006
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
FG00012 subjects
FG0017 subjects
FG0029 subjects
FG0039 subjects
FG0048 subjects
FG00555 subjects
FG00634 subjects
COMPLETED
Participants remained on study until disease progression or unacceptable toxicity. "Reason Not Completed" rows display participants' primary reason for exiting the study.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
BG005
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
BG006
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG0017
BG0029
BG0039
BG0048
BG00555
BG00634
BG007134
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
BG00066.3± 13.13
BG00158.4± 7.63
BG00265.3± 13.44
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
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
Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
The dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A Dose Level Review Committee evaluated safety data following completion of each dose observation period of the Phase 1b portion.
All-Treated Analysis Population (Phase 1b): participants who received any dose of study drug(s).
Posted
Number
mg
Estimated median time on study in Phase 1b was 59.6 months.
ID
Title
Description
OG000
All Phase 1b Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00045
Title
Denominators
Categories
Title
Measurements
OG00020
Primary
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization > 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events were those that were considered possibly related or related to study drug per investigator's judgment. Events were graded per the national Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03: Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening; grade 5=death.
All-Treated Analysis Population (Phase 1): participants who received any dose of study drug(s).
Posted
Count of Participants
Participants
No
From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Primary
Phase 2: Overall Response Rate (ORR)
The ORR was defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR), according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014), as assessed by the investigator in response-evaluable population. The 95% confidence interval (CI) was calculated using the exact method.
Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
Posted
Number
95% Confidence Interval
percentage of participants
Estimated median time on study in Phase 2 was 35.0 months.
ID
Title
Description
OG000
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG001
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Secondary
Phase 1b: ORR
The ORR was defined as the percentage of participants who achieve either a PR or CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. The 95% CI was calculated using the exact method.
Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
Posted
Number
95% Confidence Interval
percentage of participants
Estimated median time on study in Phase 1b was 59.6 months.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Secondary
Phase 1b: Complete Response (CR) Rate
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease, as assessed by the Investigator.
Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
Posted
Number
percentage of participants
Estimated median time on Phase 1b study was 59.6 months.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Secondary
Phase 2: CR Rate
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (see Cheson, 2014 for detailed criteria) in response-evaluable population, as assessed by the Investigator.
Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
Posted
Number
percentage of participants
Estimated median time on study in Phase 2 was 35.0 months.
ID
Title
Description
OG000
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG001
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG002
Secondary
Phase 2: Duration of Response (DOR)
DOR is defined as the time from the date of the first documented response (CR or PR) to the first documented evidence of disease progression (PD) according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause. For participants who had achieved an overall response but did not die or progress at the time of analysis, DOR was censored on the date of the last adequate post-baseline disease assessment, or on the date of the first occurrence of response (CR or PR) if there was no disease assessment afterwards. 2-sided 95% CI is estimated by Kaplan-Meier method.
All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s). Participant who achieved Overall Response.
Posted
Median
95% Confidence Interval
months
Estimated median time on study in Phase 2 was 35.0 months.
ID
Title
Description
OG000
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG001
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Secondary
Phase 2: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to confirmed PD according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause, whichever occurred first. For participants without disease progression or death, PFS data was censored at the date of the last tumor assessment. 2 sided 95% CI is estimated by Kaplan-Meier method.
All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s).
Posted
Median
95% Confidence Interval
months
Estimated median time on study in Phase 2 was 35.0 months.
ID
Title
Description
OG000
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG001
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Secondary
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of the first dose of study drug to the date of death due to any cause. For participants not known to have died at or prior to the database lock date, OS data was censored at the date last known alive. Participants who withdrew consent prior to study closure were censored on the date of the consent withdrawal. 2-sided 95% CI was estimated by Kaplan-Meier method.
All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s).
Posted
Median
95% Confidence Interval
months
Estimated median time on study in Phase 2 was 35.0 months.
ID
Title
Description
OG000
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG001
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Secondary
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization > 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events were those that were considered possibly related or related to study drug per investigator's judgment. Events were graded per the national Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03: Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening; grade 5=death.
All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s).
Posted
Count of Participants
Participants
No
From first dose of study drug up to 30 days after last dose of study drug. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
ID
Title
Description
OG000
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Time Frame
All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Description
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles
5
8
6
8
8
8
EG005
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
33
55
32
55
54
55
EG006
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
22
34
25
34
34
34
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected55 at risk
EG0060 events0 affected34 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HAEMOLYTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ATRIAL FLUTTER
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GASTRIC HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GASTROSPLENIC FISTULA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INCARCERATED INGUINAL HERNIA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ASTHENIA
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CATHETER SITE PAIN
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CHILLS
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FATIGUE
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PYREXIA
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
BILE DUCT STENOSIS
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CHOLECYSTITIS CHRONIC
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GALLBLADDER ENLARGEMENT
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ACUTE SINUSITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0023 events1 affected9 at risk
EG003
CELLULITIS ORBITAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ESCHERICHIA SEPSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HAEMATOMA INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION BACTERIAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LYMPHANGITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NEUTROPENIC SEPSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PARAINFLUENZAE VIRUS INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PERITONITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected9 at risk
EG003
PNEUMONIA BACTERIAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PNEUMONIA VIRAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SALMONELLA BACTERAEMIA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
WOUND SEPSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FEMORAL NECK FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
UPPER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
FAILURE TO THRIVE
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MOBILITY DECREASED
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SPINAL OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ACUTE MYELOID LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BOWEN'S DISEASE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DIFFUSE LARGE B-CELL LYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected9 at risk
EG003
INTRADUCTAL PROLIFERATIVE BREAST LESION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LUNG NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MYELODYSPLASTIC SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OCULAR LYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
EMBOLIC CEREBRAL INFARCTION
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LOSS OF CONSCIOUSNESS
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DELIRIUM
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYDRONEPHROSIS
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PROSTATIC OBSTRUCTION
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PLEURISY
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PURPURA
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0006 events4 affected12 at risk
EG0010 events0 affected7 at risk
EG0026 events3 affected9 at risk
EG00322 events3 affected9 at risk
EG0046 events2 affected8 at risk
EG00588 events17 affected55 at risk
EG00616 events11 affected34 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
INCREASED TENDENCY TO BRUISE
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected12 at risk
EG0011 events1 affected7 at risk
EG0023 events2 affected9 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0007 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
LYMPHOCYTOSIS
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG00013 events5 affected12 at risk
EG0010 events0 affected7 at risk
EG00246 events6 affected9 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SPONTANEOUS HAEMATOMA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0008 events4 affected12 at risk
EG0015 events2 affected7 at risk
EG0029 events4 affected9 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected9 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DEAFNESS
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
HYPOACUSIS
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CATARACT
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
CHALAZION
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DRY AGE-RELATED MACULAR DEGENERATION
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DRY EYE
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
EXOPHTHALMOS
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
EYE OEDEMA
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
EYE PAIN
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
EYE PRURITUS
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
METAMORPHOPSIA
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OCULAR HYPERAEMIA
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OPTIC NERVE COMPRESSION
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
PERIORBITAL SWELLING
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
PHOTOPHOBIA
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
TRICHIASIS
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected12 at risk
EG0012 events2 affected7 at risk
EG0024 events4 affected9 at risk
EG003
DEFAECATION URGENCY
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00022 events9 affected12 at risk
EG0014 events3 affected7 at risk
EG0023 events3 affected9 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
EPIGASTRIC DISCOMFORT
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FAECES DISCOLOURED
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GINGIVAL PAIN
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GINGIVAL SWELLING
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
GLOSSODYNIA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
HAEMORRHOIDAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPERCHLORHYDRIA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MELAENA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00010 events7 affected12 at risk
EG0014 events3 affected7 at risk
EG0024 events3 affected9 at risk
EG003
ORAL DISORDER
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PARAESTHESIA ORAL
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SALIVARY GLAND CALCULUS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
TONGUE ULCERATION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
TOOTH LOSS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected12 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ADVERSE DRUG REACTION
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ASTHENIA
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CHEST PAIN
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
CHILLS
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0023 events2 affected9 at risk
EG003
FACE OEDEMA
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
FATIGUE
General disorders
MedDRA 23.1
Systematic Assessment
EG0008 events6 affected12 at risk
EG0013 events3 affected7 at risk
EG0029 events5 affected9 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INFUSION SITE EXTRAVASATION
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INFUSION SITE SWELLING
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MALAISE
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
NODULE
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OEDEMA
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected7 at risk
EG0023 events3 affected9 at risk
EG003
PAIN
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected7 at risk
EG0022 events2 affected9 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PYREXIA
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected7 at risk
EG0024 events2 affected9 at risk
EG003
VESSEL PUNCTURE SITE BRUISE
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
HEPATIC CYST
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HEPATIC FUNCTION ABNORMAL
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HEPATOMEGALY
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPOGAMMAGLOBULINAEMIA
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ARTHRITIS BACTERIAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
BLISTER INFECTED
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CHRONIC SINUSITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CLOSTRIDIUM COLITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
CONJUNCTIVITIS BACTERIAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CORONAVIRUS INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CYSTITIS KLEBSIELLA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ESCHERICHIA URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
EYE INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
IMPETIGO
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NAIL INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ONYCHOMYCOSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PSEUDOMONAS INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PUSTULE
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events1 affected7 at risk
EG0022 events2 affected9 at risk
EG003
SINUSITIS BACTERIAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SUBCUTANEOUS ABSCESS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
TINEA PEDIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
WOUND ABSCESS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
WOUND INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
WOUND INFECTION STAPHYLOCOCCAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
EYE CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0004 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
IMPACTED FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LUMBAR VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MOUTH INJURY
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
NAIL INJURY
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
POST PROCEDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SCRATCH
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SKIN ABRASION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
WOUND
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD CREATINE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BODY TEMPERATURE FLUCTUATION
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CARDIAC MURMUR
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0023 events1 affected9 at risk
EG003
CREATININE RENAL CLEARANCE DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
STAPHYLOCOCCUS TEST POSITIVE
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
VITAMIN D DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events2 affected7 at risk
EG0022 events2 affected9 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected7 at risk
EG0027 events4 affected9 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ENZYME ABNORMALITY
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0026 events1 affected9 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0007 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0008 events4 affected12 at risk
EG0011 events1 affected7 at risk
EG0027 events3 affected9 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0024 events2 affected9 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0004 events4 affected12 at risk
EG0010 events0 affected7 at risk
EG0024 events2 affected9 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0024 events3 affected9 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCLE ATROPHY
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events1 affected7 at risk
EG0023 events2 affected9 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCULOSKELETAL DISCOMFORT
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MUSCULOSKELETAL STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected7 at risk
EG0025 events2 affected9 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RHABDOMYOLYSIS
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CANCER PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
LIPOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
APHASIA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ATAXIA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
BALANCE DISORDER
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0005 events4 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
DIZZINESS POSTURAL
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DYSARTHRIA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HEAD DISCOMFORT
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected9 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PARKINSON'S DISEASE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PERIPHERAL SENSORIMOTOR NEUROPATHY
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RESTLESS LEGS SYNDROME
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SPEECH DISORDER
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
TREMOR
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DISORIENTATION
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
STRESS
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLADDER TRABECULATION
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
URETHRAL STENOSIS
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
GENITAL RASH
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
OEDEMA GENITAL
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ALLERGIC SINUSITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
APHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected12 at risk
EG0010 events0 affected7 at risk
EG0024 events2 affected9 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events1 affected7 at risk
EG0022 events1 affected9 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 events2 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
LUNG DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
NASAL DRYNESS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
NASAL SEPTUM PERFORATION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
PARANASAL SINUS HYPERSECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
RESPIRATORY DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0023 events2 affected9 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
UPPER RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
YAWNING
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
BLISTER
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
BLOOD BLISTER
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
MACULE
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
ONYCHOCLASIS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PETECHIAE
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
PURPURA
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0005 events2 affected12 at risk
EG0012 events1 affected7 at risk
EG00211 events5 affected9 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SCAB
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SKIN DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SKIN EXFOLIATION
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SKIN HYPERPIGMENTATION
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
SKIN IRRITATION
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
STASIS DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
PHYSICAL ASSAULT
Social circumstances
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
PERIPHERAL COLDNESS
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
VARICOSE VEIN
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Institution/Investigator will not publish without Sponsor prior review and approval
Institution/Investigator will not publish until the earlier of (i) results of study are submitted for publication (ii) notification that submission of the multicenter results are no longer planned (iii) 18 months after study termination.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00012
OG0017
OG0029
OG0039
OG0048
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00012
OG0017
OG0029
OG0039
OG0048
Any Grade >=3 TEAE
Title
Measurements
OG00011
OG0016
OG0029
OG003
Any Study Drug-Related TEAE
Title
Measurements
OG00012
OG0015
OG0029
OG003
Any Grade >=3 Study Drug-Related TEAE
Title
Measurements
OG00010
OG0013
OG0028
OG003
Any Ibrutinib-Related TEAE
Title
Measurements
OG00012
OG0015
OG0029
OG003
Any Grade >=3 Ibrutinib-Related TEAE
Title
Measurements
OG00010
OG0013
OG0027
OG003
Any Lenalidomide-Related TEAE
Title
Measurements
OG00012
OG0015
OG0029
OG003
Any Grade >=3 Lenalidomide-Related TEAE
Title
Measurements
OG0009
OG0013
OG0028
OG003
Any Rituximab-Related TEAE
Title
Measurements
OG0006
OG0014
OG0027
OG003
Any Grade >= 3 Rituximab-Related TEAE
Title
Measurements
OG0001
OG0012
OG0027
OG003
Any TEAE Leading to Dose Reduction of Any Study Drug
Title
Measurements
OG0004
OG0010
OG0024
OG003
Any TEAE Leading to Dose Reduction of Ibrutinib
Title
Measurements
OG0003
OG0010
OG0024
OG003
Any TEAE Leading to Dose Reduction of Lenalidomide
Title
Measurements
OG0002
OG0010
OG0023
OG003
Any TEAE Leading to Dose Delay of Any Study Drug
Title
Measurements
OG0006
OG0014
OG0027
OG003
Any TEAE Leading to Dose Delay of Ibrutinib
Title
Measurements
OG0006
OG0014
OG0027
OG003
Any TEAE Leading to Dose Delay of Lenalidomide
Title
Measurements
OG0006
OG0013
OG0027
OG003
Any TEAE Leading to Dose Delay of Rituximab
Title
Measurements
OG0004
OG0011
OG0026
OG003
Any TEAE Leading to Discontinuation of Any Study Drug
Title
Measurements
OG0004
OG0012
OG0023
OG003
Any TEAE Leading to Discontinuation of Ibrutinib Dose
Title
Measurements
OG0004
OG0012
OG0023
OG003
Any TEAE Leading to Discontinuation of Lenalidomide Dose
Title
Measurements
OG0004
OG0012
OG0023
OG003
Any TEAE Leading to Discontinuation of Rituximab Dose
Title
Measurements
OG0003
OG0012
OG0023
OG003
Any Serious TEAE
Title
Measurements
OG0004
OG0016
OG0027
OG003
Any Grade >=3 Serious TEAE
Title
Measurements
OG0004
OG0016
OG0026
OG003
Any Treatment-Related Serious TEAE
Title
Measurements
OG0000
OG0012
OG0024
OG003
Any Ibrutinib-Related Serious TEAE
Title
Measurements
OG0000
OG0012
OG0024
OG003
Any Lenalidomide-Related Serious TEAE
Title
Measurements
OG0000
OG0012
OG0024
OG003
Any Rituximab-Related Serious TEAE
Title
Measurements
OG0000
OG0012
OG0022
OG003
Any Fatal TEAE
Title
Measurements
OG0000
OG0012
OG0022
OG003
OG002
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG005
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG005
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG0039
OG0048
OG00540
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG0010
OG00242.9
OG00311.1
OG00450.0
OG00527.5
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00053
OG00132
OG00289
Title
Denominators
Categories
Title
Measurements
OG00032.1
OG00121.9
OG00228.2
OG002
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00028
OG00114
OG00242
Title
Denominators
Categories
Title
Measurements
OG00038.3(3.7 to NA)The upper confidence limit is not estimable per the Brookmeyer and Crowley (1982) method.
OG00128.6(2.8 to 28.6)
OG00238.3(9.5 to NA)The upper confidence limit is not estimable per the Brookmeyer and Crowley (1982) method.
OG002
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00055
OG00134
OG00289
Title
Denominators
Categories
Title
Measurements
OG0005.4(3.4 to 11.3)
OG0014.7(2.6 to 24.8)
OG0025.4(3.4 to 6.3)
OG002
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00055
OG00134
OG00289
Title
Denominators
Categories
Title
Measurements
OG00014.7(9.7 to 32.8)
OG00111.6(5.7 to NA)The upper confidence limit is not estimable per the Brookmeyer and Crowley (1982) method.
OG00214.2(9.7 to 28.1)
OG001
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
OG002
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 to 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Units
Counts
Participants
OG00055
OG00134
OG00289
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00055
OG00134
OG00289
Any Grade >=3 TEAE
Title
Measurements
OG00051
OG00130
OG00281
Any Study Drug-Related TEAE
Title
Measurements
OG00052
OG00133
OG00285
Any Grade >=3 Study Drug-Related TEAE
Title
Measurements
OG00041
OG00125
OG00266
Any Ibrutinib-Related TEAE
Title
Measurements
OG00050
OG00132
OG00282
Any Grade >=3 Ibrutinib-Related TEAE
Title
Measurements
OG00036
OG00124
OG00260
Any Lenalidomide-Related TEAE
Title
Measurements
OG00051
OG00132
OG00283
Any Grade >=3 Lenalidomide-Related TEAE
Title
Measurements
OG00040
OG00125
OG00265
Any Rituximab-Related TEAE
Title
Measurements
OG00037
OG00125
OG00262
Any Grade >= 3 Rituximab-Related TEAE
Title
Measurements
OG00018
OG00113
OG00231
Any TEAE Leading to Dose Reduction of Any Study Drug
Title
Measurements
OG00023
OG00114
OG00237
Any TEAE Leading to Dose Reduction of Ibrutinib
Title
Measurements
OG00012
OG0019
OG00221
Any TEAE Leading to Dose Reduction of Lenalidomide
Title
Measurements
OG00021
OG00114
OG00235
Any TEAE Leading to Dose Delay of Any Study Drug
Title
Measurements
OG00040
OG00129
OG00269
Any TEAE Leading to Dose Delay of Ibrutinib
Title
Measurements
OG00038
OG00128
OG00266
Any TEAE Leading to Dose Delay of Lenalidomide
Title
Measurements
OG00037
OG00126
OG00263
Any TEAE Leading to Dose Delay of Rituximab
Title
Measurements
OG00010
OG0016
OG00216
Any TEAE Leading to Discontinuation of Any Study Drug
Title
Measurements
OG00011
OG0017
OG00218
Any TEAE Leading to Discontinuation of Ibrutinib Dose
Title
Measurements
OG00011
OG0015
OG00216
Any TEAE Leading to Discontinuation of Lenalidomide Dose
Title
Measurements
OG00011
OG0017
OG00218
Any TEAE Leading to Discontinuation of Rituximab Dose