A Study to Evaluate Safety, Pharmacokinetics, Pharmacodyn... | NCT02329847 | Trialant
NCT02329847
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
May 25, 2025Actual
Enrollment
144Actual
Phase
Phase 1Phase 2
Conditions
Hematologic Neoplasms
Interventions
Ibrutinib
Nivolumab
Countries
United States
Australia
Israel
Poland
Spain
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT02329847
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR106681
Secondary IDs
ID
Type
Description
Link
PCI-32765LYM1002
Other Identifier
Janssen Research & Development, LLC
2014-005191-28
EudraCT Number
Brief Title
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies
Official Title
A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Subjects With Hematologic Malignancies
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
May 2025
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 11, 2015Actual
Primary Completion Date
Feb 9, 2022Actual
Completion Date
Feb 9, 2022Actual
First Submitted Date
Dec 30, 2014
First Submission Date that Met QC Criteria
Dec 30, 2014
First Posted Date
Jan 1, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 9, 2023
Results First Submitted that Met QC Criteria
May 19, 2023
Results First Posted Date
Jun 15, 2023Actual
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
May 22, 2025
Last Update Posted Date
May 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Name
Class
Bristol-Myers Squibb
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.
Detailed Description
This is an open-label study, which consists of Part A (Dose Optimization Cohorts) and Part B (Expansion Cohorts). Part A consists of two dose optimization cohorts (cohort A1 and cohort A2) will determine the RP2D for the combination based on safety, pharmacokinetic, and pharmacodynamic assessments in participants with relapsed/refractory CLL/SLL or B-cell non-Hodgkin lymphoma (B-NHL). Part B consists 3 participant populations to further evaluate the safety and clinical activity of ibrutinib in combination with nivolumab: Cohort B1 (participants with CLL/SLL with del 17p or del 11q), Cohort B2 (participants with FL), Cohort B3 (participants with DLBCL) and Cohort B4 (participants with Richter syndrome). Part A and B will consist of Screening Period (28 days before enrollment), Treatment Period and Follow up Period (every 3 months until death or the end of study). Participants will receive nivolumab intravenously (Day 1 of every cycle) and ibrutinib orally once daily on a 14-day cycle. Efficacy will primarily be evaluated by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and International Working Group (IWG) for lymphoma guidelines. Participants' safety will be monitored throughout the study. Further exploration of pharmacokinetic/pharmacodynamic and biomarker information will be assessed throughout the trial.
Conditions Module
Conditions
Hematologic Neoplasms
Keywords
Hematologic Neoplasms
JNJ54179060
Ibrutinib
Nivolumab
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
144Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A1
Experimental
Participants will receive ibrutinib 420 milligram (mg) capsule orally once daily and nivolumab intravenously as 3 milligram/kilogram (mg/kg) every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Drug: Nivolumab
Cohort A2
Experimental
Participants will receive ibrutinib 560 mg capsule orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Drug: Nivolumab
Cohort B1
Experimental
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Drug: Nivolumab
Cohort B2
Experimental
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Drug: Nivolumab
Cohort B3
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ibrutinib
Drug
Participants will receive oral capsule of ibrutinib once daily as either 420 mg or 560 mg or at recommended Phase 2 dose in any of the cohort.
Cohort A1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort
ORR is percentage of participants achieving a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR) or PR. IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/L, platelets >100*10^9/L, Hgb >11 g/dL and absolute lymphocyte count <4000/mcL; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all. This outcome measure was planned to be analyzed for specified arm only.
ORR defined as percentage of participants achieving a CR, CRi, nPR or PR. As per Non-Hodgkin Lymphoma, Cheson 2014, CR is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive disease (PD) >= 50% increase from nadir in the sum of the products of at least two lymph nodes, or appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. This outcome measure was planned to be analyzed for specified arms only.
Up to 6 years 11 months
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs for the treatment phase included events with an onset date/time on or after the start of study intervention through end of study were considered as treatment-emergent.
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DoR): Study Cohort
DOR is defined as the interval between the date of initial documentation of a response including partial response with lymphocytosis (PRL) and date of first documented evidence of progressive disease or death or date of censoring. iWCLL 2008 criteria for progressive disease: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (>=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1, or 2
Adequate bone marrow, liver, and renal function defined as: 1) Absolute neutrophil count (ANC) greater than equal to (>=) 1.5* 10^9cells/litre (L); 2) Platelets >=75 x 109cells/L without transfusion support within 7 days prior to test; 3) Hemoglobin >= 8 gram/deciliter (g/dL) without transfusion support within 7 days prior to test 4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than equal to (<=) 2.5 * upper limit of normal (ULN) 5) Total bilirubin less than (<) 2 milligram/deciliter (mg/dL) 6) Creatinine determined by serum creatinine levels <=1.5 * ULN or a calculated creatinine clearance of >= 50 mL/min/1.73 m^2
Relapsed refractory disease after at least 1 but not more than 4 lines of previous systemic therapy
Measurable disease (NHL: At least 1 measurable site of disease [>1.5 centimeter [cm] in the long axis regardless of short axis measurement or >1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions])
Cohort B-1: SLL/CLL: 1) Deletion of short arm of chromosome 17 or 11 q based on institutional assessment 2) Relapsed/refractory after at least 1 prior systemic therapy 3) Active disease based in IWCLL criteria
Cohort B-2: 1) B- cell follicular lymphoma Grade 1, 2, or 3a (WHO criteria) 2) Relapsed/refractory disease >= 2 lines separated by Progression, prior treatment (or not eligible for receiving) CD20 antibody 3) Measurable disease (IWG -Lugano 2014)
Cohort B-3: 1) Histologically-confirmed DLBCL 2) Prior standard rituximab + anthracyclin containing regimen, received or not eligible or considered candidate of HD-ASCT 3) Measurable disease (IWG -Lugano 2014)
Cohort B-4: 1) Histologically-confirmed Richter syndrome defined as transformation of CLL or SLL into an aggressive lymphoma 2) Previously treated with at least one line of standard, systemic chemotherapy or not eligible for standard therapy 3) At least 1 measurable site of disease based on the Revised Response Criteria for Malignant Lymphoma
Exclusion Criteria:
Prior therapy or surgery (3 to 10 weeks depending type)
Prior BTK inhibitor or anti PD1, anti PDL1, anti PD-L2 and anti-CD137, anti-cytotoxic T-lymphocyte associated antigen (CTLA-4) antibody
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification, or congenital long QT syndrome, or QT interval corrected for heart rate, using Fridericia formula (QTcF) at Screening greater than (>) 470 milliseconds (ms)
History of stroke or intracranial hemorrhage within 6 months prior to the first dose of ibrutinib
Requires treatment with anticoagulation with warfarin or equivalent vitamin K antagonists
Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Bruscaggin A, di Bergamo LT, Spina V, Hodkinson B, Forestieri G, Bonfiglio F, Condoluci A, Wu W, Pirosa MC, Faderl MR, Koch R, Schaffer M, Alvarez JD, Fourneau N, Gerber B, Stussi G, Zucca E, Balasubramanian S, Rossi D. Circulating tumor DNA for comprehensive noninvasive monitoring of lymphoma treated with ibrutinib plus nivolumab. Blood Adv. 2021 Nov 23;5(22):4674-4685. doi: 10.1182/bloodadvances.2021004528.
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 12, 2020
Feb 9, 2023
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
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Drug: Nivolumab
Cohort B4
Experimental
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Drug: Nivolumab
Cohort A2
Cohort B1
Cohort B2
Cohort B3
Cohort B4
JNJ54179060
Nivolumab
Drug
Participants will receive nivolumab intravenously as 3 mg/kg on Day 1 every cycle of 14 days.
Cohort A1
Cohort A2
Cohort B1
Cohort B2
Cohort B3
Cohort B4
BMS-936558
Up to 6 years 10 months
Up to 6 years 11 months
Duration of Stable Disease or Better: Study Cohort
Duration of stable disease or better was defined as duration from the start of the treatment until the criteria for progression were met. IWCLL 2008 criteria for progressive disease: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Up to 6 years and 11 months
Progression-free Survival (PFS): Study Cohort
PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. IWCLL 2008 criteria for progressive disease: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Up to 6 years 11 months
Overall Survival (OS): Study Cohort
OS was defined as duration from the date of first dose of study drug to the date of the participant's death.
Up to 6 years 11 months
Percentage of Participants With Lymphoma-related Symptoms: Study Cohort
Percentage of participants with lymphoma-related symptoms were reported. These symptoms included B-symptoms, recurrent fever, night sweats, weight loss, other disease-related symptoms, itching, fatigue, physical discomfort and any other.
Up to 6 years 11 months
Bedford Park
Australia
Darlinghurst
Australia
Woolloongabba
Australia
Haifa
Israel
Jeursalem
Israel
Ramat Gan
Israel
Tel Aviv
Israel
Chorzów
Poland
Gdansk
Poland
Krakow
Poland
Wroclaw
Poland
Barcelona
Spain
Madrid
Spain
Salamanca
Spain
Ankara
Turkey (Türkiye)
Istanbul
Turkey (Türkiye)
Izmir
Turkey (Türkiye)
Derived
Younes A, Brody J, Carpio C, Lopez-Guillermo A, Ben-Yehuda D, Ferhanoglu B, Nagler A, Ozcan M, Avivi I, Bosch F, Caballero Barrigon MD, Hellmann A, Kuss B, Ma DDF, Demirkan F, Yagci M, Horowitz NA, Marlton P, Cordoba R, Wrobel T, Buglio D, Streit M, Hodkinson BP, Schaffer M, Alvarez J, Ceulemans R, Balasubramanian S, de Jong J, Wang SS, Fourneau N, Jurczak W. Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study. Lancet Haematol. 2019 Feb;6(2):e67-e78. doi: 10.1016/S2352-3026(18)30217-5. Epub 2019 Jan 11.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
FG0007 subjects
FG0017 subjects
FG00236 subjects
FG00335 subjects
FG00439 subjects
FG00520 subjects
Treated (Safety Analysis Set)
FG0007 subjects
FG0017 subjects
FG00235 subjects
FG00335 subjects
FG00437 subjects
FG00520 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0007 subjects
FG0017 subjects
FG00235 subjects
FG00335 subjects
FG00439 subjects
FG00520 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0014 subjects
FG00222 subjects
FG00312 subjects
FG00420 subjects
FG00513 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0025 subjects
FG0037 subjects
FG004
Other
FG0001 subjects
FG0012 subjects
FG0026 subjects
FG00313 subjects
FG004
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab).
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0017
BG00235
BG00335
BG00437
BG00520
BG006141
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
BG00061± 18.08
BG00165.9± 13.96
BG00264.3± 9.57
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
AUSTRALIA
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
Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort
ORR is percentage of participants achieving a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR) or PR. IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/L, platelets >100*10^9/L, Hgb >11 g/dL and absolute lymphocyte count <4000/mcL; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all. This outcome measure was planned to be analyzed for specified arm only.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). The ORR evaluation criteria were disease specific and hence the analysis was done as per disease cohorts for this outcome measure as pre-planned.
Posted
Number
Percentage of Participants
Up to 6 years 11 months
ID
Title
Description
OG000
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
ORR defined as percentage of participants achieving a CR, CRi, nPR or PR. As per Non-Hodgkin Lymphoma, Cheson 2014, CR is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive disease (PD) >= 50% increase from nadir in the sum of the products of at least two lymph nodes, or appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. This outcome measure was planned to be analyzed for specified arms only.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). The ORR evaluation criteria were disease specific and hence the analysis was done as per disease cohorts for this outcome measure as pre-planned.
Posted
Number
Percentage of Participants
Up to 6 years 11 months
ID
Title
Description
OG000
Ibrutinib and Nivolumab: Small Lymphocytic Lymphoma (SLL)
Participants with SLL in Cohort B1, received ibrutinib 420 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Primary
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs for the treatment phase included events with an onset date/time on or after the start of study intervention through end of study were considered as treatment-emergent.
The safety population included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Secondary
Duration of Response (DoR): Study Cohort
DOR is defined as the interval between the date of initial documentation of a response including partial response with lymphocytosis (PRL) and date of first documented evidence of progressive disease or death or date of censoring. iWCLL 2008 criteria for progressive disease: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (>=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and achieved either PR or better (including PRL only for CLL participants).
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
OG001
Secondary
Duration of Stable Disease or Better: Study Cohort
Duration of stable disease or better was defined as duration from the start of the treatment until the criteria for progression were met. IWCLL 2008 criteria for progressive disease: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and met criteria for progressive disease. Here 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
OG001
Secondary
Progression-free Survival (PFS): Study Cohort
PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. IWCLL 2008 criteria for progressive disease: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and met criteria for progressive disease.
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Secondary
Overall Survival (OS): Study Cohort
OS was defined as duration from the date of first dose of study drug to the date of the participant's death.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and were responders.
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Percentage of Participants With Lymphoma-related Symptoms: Study Cohort
Percentage of participants with lymphoma-related symptoms were reported. These symptoms included B-symptoms, recurrent fever, night sweats, weight loss, other disease-related symptoms, itching, fatigue, physical discomfort and any other.
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab).
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
OG002
Time Frame
Up to 6 years 11 months
Description
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
13
20
15
20
19
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0022 affected35 at risk
EG0030 affected35 at risk
EG0043 affected37 at risk
EG0050 affected20 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Cardiotoxicity
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Cataract
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gastric Haemorrhage
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gastrointestinal Inflammation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Large Intestine Perforation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Oesophageal Compression
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Asthenia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Chills
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Fatigue
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Multiple Organ Dysfunction Syndrome
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Unevaluable Event
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Biliary Obstruction
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Portal Vein Thrombosis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Encephalitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Enterococcal Bacteraemia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Otitis Media
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Otitis Media Chronic
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Pneumonia Fungal
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pneumonia Klebsiella
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Pneumonia Parainfluenzae Viral
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Respiratory Syncytial Virus Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Respiratory Tract Infection Bacterial
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Rhinovirus Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Septic Shock
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Urinary Tract Infection Bacterial
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Wound Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pancreatic Injury
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Immunoglobulins Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Transaminases Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Diabetes Mellitus Inadequate Control
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Leukaemic Infiltration
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Malignant Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Penile Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Renal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Organising Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Respiratory Arrest
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0029 affected35 at risk
EG0035 affected35 at risk
EG00411 affected37 at risk
EG0058 affected20 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG00220 affected35 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG00211 affected35 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Atrioventricular Block First Degree
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Euthyroid Sick Syndrome
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Eye Haemorrhage
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Miosis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Anal Ulcer
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected7 at risk
EG0011 affected7 at risk
EG00213 affected35 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gastric Fistula
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Gingival Bleeding
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0020 affected35 at risk
EG003
Intra-Abdominal Haematoma
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0023 affected35 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0022 affected35 at risk
EG003
Asthenia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0023 affected35 at risk
EG003
Chills
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Fatigue
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0013 affected7 at risk
EG0026 affected35 at risk
EG003
Gait Disturbance
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Generalised Oedema
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Inflammation
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0027 affected35 at risk
EG003
Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Peripheral Swelling
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0022 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0012 affected7 at risk
EG00210 affected35 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Secondary Immunodeficiency
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0024 affected35 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0022 affected35 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Cytomegalovirus Infection Reactivation
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Folliculitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gallbladder Abscess
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Herpes Simplex
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Klebsiella Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Laryngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0024 affected35 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Otitis Media
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Rhinovirus Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG00211 affected35 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Viral Pharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Wound Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Wound Infection Staphylococcal
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Nasal Injury
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0024 affected35 at risk
EG003
Amylase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0025 affected35 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0024 affected35 at risk
EG003
Blood Alkaline Phosphatase
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0023 affected35 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Blood Uric Acid Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Lipase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0012 affected7 at risk
EG0028 affected35 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Serum Ferritin Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Glucose Tolerance Impaired
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0024 affected35 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0028 affected35 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG00210 affected35 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0024 affected35 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0025 affected35 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0024 affected35 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Tumour Haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected35 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0022 affected35 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0014 affected7 at risk
EG0024 affected35 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Laryngeal Inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Organising Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0023 affected35 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0022 affected35 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0020 affected35 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0026 affected35 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected35 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected35 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected35 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0024 affected35 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0021 affected35 at risk
EG003
Pallor
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Phlebitis
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
White Coat Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected35 at risk
EG003
Though it was planned to administer Ibrutinib 280 milligrams (mg) to participants in case the toxicity increased, no participants received ibrutinib 280 mg in the study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
OG002
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
OG003
Ibrutinib and Nivolumab: Richter
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Units
Counts
Participants
OG0002
OG0011
OG00226
OG00312
OG00415
OG00513
Title
Denominators
Categories
Title
Measurements
OG00011.5(2.4 to 20.7)
OG001NA(NA to NA)Here 'NA' indicates that median and 95% CI could not be estimated due to less number of participants with events.
OG00219.2(9.4 to 19.4)
OG00310.2(5.1 to 17.8)
OG004NA(4.6 to NA)Here 'NA' indicates that median and upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0056.9(1.3 to NA)Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Units
Counts
Participants
OG0006
OG0015
OG00216
OG00326
OG00422
OG00511
Title
Denominators
Categories
Title
Measurements
OG0002.0(1.1 to 24.8)
OG0019.1(0.7 to 20.8)
OG00221.6(12.0 to 21.6)
OG0037.6(2.9 to 12.7)
OG0043.2(2.1 to NA)Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0055.0(2.4 to NA)Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Units
Counts
Participants
OG0004
OG0013
OG00211
OG0039
OG00416
OG0058
Title
Denominators
Categories
Title
Measurements
OG00012.4(2.0 to 28.8)
OG001NA(0.8 to NA)Here 'NA' indicates that median and upper limit of 95% CI could not be estimated due to less number of participants with events.
OG002NA(21.6 to NA)Here 'NA' indicates that median and upper limit of 95% CI could not be estimated due to less number of participants with events.
OG003NA(NA to NA)Here 'NA' indicates that median and 95% CI could not be estimated due to less number of participants with events.
OG00419.0(7.7 to NA)Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
OG00510.3(4.8 to NA)Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.