Study of the Safety and Pharmacokinetics of BGB-3111 in S... | NCT02343120 | Trialant
NCT02343120
Sponsor
BeiGene
Status
Completed
Last Update Posted
Apr 28, 2022Actual
Enrollment
385Actual
Phase
Phase 1Phase 2
Conditions
B-cell Malignancies
Interventions
Zanubrutinib
Countries
United States
Australia
Italy
New Zealand
South Korea
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02343120
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BGB-3111-AU-003
Secondary IDs
ID
Type
Description
Link
2016-003364-39
EudraCT Number
Brief Title
Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Official Title
A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Acronym
Not provided
Organization
BeiGeneINDUSTRY
Status Module
Record Verification Date
Apr 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 4, 2014Actual
Primary Completion Date
Mar 31, 2021Actual
Completion Date
Mar 31, 2021Actual
First Submitted Date
Jan 9, 2015
First Submission Date that Met QC Criteria
Jan 15, 2015
First Posted Date
Jan 21, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 30, 2022
Results First Submitted that Met QC Criteria
Mar 30, 2022
Results First Posted Date
Apr 27, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 26, 2022
Last Update Posted Date
Apr 28, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BeiGeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies.
Detailed Description
Not provided
Conditions Module
Conditions
B-cell Malignancies
Keywords
Not provided
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
385Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Zanubrutinib
Experimental
Participants were administered up to 320 mg total daily dose of zanubrutinib until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Drug: Zanubrutinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Zanubrutinib
Drug
Oral administration by capsule
Zanubrutinib
BGB-3111
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1 and Part 2: Number of Participants With Adverse Events
Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements
Up to approximately 6 years and 7 months
Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib
RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD
Month 9
Secondary Outcomes
Measure
Description
Time Frame
Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 18 years, voluntarily consented to the study.
WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.
Requirement for treatment in the opinion of the investigator.
Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L; participants with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10^9/L.
Adequate renal function, as defined by creatinine clearance of ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
Adequate liver function, as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN), and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).
International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
Female participants of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
Male participants must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.
Exclusion Criteria:
Current central nervous system (CNS) involvement by disease
Allogeneic stem cell transplantation within 6 months, or has active graft-versus-host disease (GVHD) requiring ongoing immunosuppression.
Receipt of the following treatment prior to first dose of zanubrutinib: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks.
Not recovered from toxicity of any prior chemotherapy to grade ≤ 1.
History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
Known HIV, or active hepatitis B or hepatitis C infection (detected positive by PCR).
Cardiovascular disease resulting in New York Heart Association function status of ≥ 3.
Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
Inability to comply with study procedures.
On medications which are cytochrome P450 (CYP) 3A inhibitors.
Tam CS, Trotman J, Opat S, Burger JA, Cull G, Gottlieb D, Harrup R, Johnston PB, Marlton P, Munoz J, Seymour JF, Simpson D, Tedeschi A, Elstrom R, Yu Y, Tang Z, Han L, Huang J, Novotny W, Wang L, Roberts AW. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019 Sep 12;134(11):851-859. doi: 10.1182/blood.2019001160. Epub 2019 Jul 24.
The study was conducted in 2 parts. The dose escalation part (Part 1) determined the recommended phase 2 dose (RP2D) and regimen and the dose expansion part (Part 2) further characterized the safety and efficacy at the RP2D.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
FG001
Part 1: 80 mg QD
Periods
Title
Milestones
Reasons Not Completed
Part 1: Dose Escalation
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 25, 2018
Mar 30, 2022
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
Brukinsa
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib
Week 2 Day 1 pre-dose and 24 hours
Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
Week 2 Day 1 pre-dose and 24 hours
Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Apparent Volume of Distribution of Zanubrutinib During the Terminal Phase (Vz/F)
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Part 1 and Part 2: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Up to 6 years and 7 months
Part 1 and Part 2: Complete Response Rate (CRR)
CRR is defined as the percentage of participants who achieve a complete response, as assessed by the investigator. For CLL/SLL, CRR includes CRi or better. For WM, CRR includes very good partial response (VGPR) or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Up to 6 years and 7 months
Part 1 and Part 2: Partial Response (PR) or Better
PR or better is defined as the percentage of participants who achieve a partial response or better, as assessed by the investigator. For CLL/SLL, includes PR, nPR, CRi, CR and for WM includes PR, VGPR, and CR. Efficacy results are reported for the B-cell malignancy subtypes chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and Waldenström macroglobulinemia (WM).
Up to 6 years and 7 months
Part 1 and Part 2: Progression-free Survival (PFS)
PFS is defined as the time from the first dose date of study drug to the date of the earliest occurrence of progressive disease or death due to any cause, whichever occurs first. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Up to 6 years and 7 months
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from the date of the first dose to death due to any cause. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Up to 6 years and 7 months
Part 1 and Part 2: Duration of Response (DOR)
DOR for responders is defined as time from the date of the earliest qualifying response to the date of progressive disease or death for any cause, whichever occurs earlier. Efficacy results are reported for responders (defined as PR or better, except CLL/SLL and WM) in each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; PR with lymphocytosis or better), Waldenstrom macroglobulinemia (WM; minor response or better), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Up to 6 years and 7 months
Number of Participants With Greater Than 75% Bruton's Tyrosine Kinase (BTK) Occupancy
Number of participants with greater than 75% BTK occupancy of zanubrutinib in peripheral blood mononuclear cells (PBMCs)
Week 1 Day 1 (W1D1) predose, W1D1 4 hours, W1D2 24 hours, W1D3 predose, and W2D1 predose
Ann Arbor
Michigan
48109
United States
Mayo Clinic
Rochester
Minnesota
55901
United States
M.D. Anderson Cancer Center
Houston
Texas
77030
United States
Concord Repatriation General Hospital
Concord
New South Wales
Australia
St George Hospital
Sydney
New South Wales
Australia
Westmead Hospital
Westmead
New South Wales
Australia
Princess Alexandra Hospital
Brisbane
Queensland
Australia
Royal Hobart Hospital
Hobart
Tasmania
Australia
Monash Health
Clayton
Victoria
Australia
Austin Health
Heidelberg
Victoria
Australia
St Vincent's Hospital
Melbourne
Victoria
Australia
Peter MacCallum Cancer Centre, East Melbourne
Parkville
Victoria
3050
Australia
Melbourne Health
Parkville
Victoria
Australia
Sir Charles Gairdner Hospital
Nedlands
Western Australia
Australia
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna
Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milan
Italy
North Shore Hospital
Auckland
New Zealand
Dong-A University Medical Centre
Busan
South Korea
Inje University Busan Paik Hospital
Busan
South Korea
National Cancer Center
Goyang-si
South Korea
Samsung Medical Center
Seoul
South Korea
Derriford Hospital
Plymouth
Devon
United Kingdom
Background
Trotman J, Opat S, Gottlieb D, Simpson D, Marlton P, Cull G, Munoz J, Tedeschi A, Roberts AW, Seymour JF, Atwal SK, Yu Y, Novotny W, Holmgren E, Tan Z, Hilger JD, Huang J, Tam CS. Zanubrutinib for the treatment of patients with Waldenstrom macroglobulinemia: 3 years of follow-up. Blood. 2020 Oct 29;136(18):2027-2037. doi: 10.1182/blood.2020006449.
Background
C.S. Tam M. Wang D. Simpson S. Opat G. Cull J. Munoz T.J. Phillips W. Kim S. Atwal R. Wei J. Huang R. Elstrom J. Trotman. UPDATED SAFETY AND EFFICACY DATA IN THE PHASE 1 TRIAL OF PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) TREATED WITH BRUTON TYROSINE KINASE (BTK) INHIBITOR ZANUBRUTINIB (BGB-3111). Hematological Oncology. 2019; 37(S2) DOI: https://doi.org/10.1002/hon.55_2630
Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
Liu Y, Ma X, Wu X, Hou X, Jin W, Fu L, Xun X, Yu Y, Shen Z. Zanubrutinib is effective in non-germinal-center B-cell-like diffuse large B-cell lymphoma with mutated CD79B, high TCL1A expression, or over- expressed MYC/BCL-2. Leuk Lymphoma. 2024 Aug;65(8):1079-1089. doi: 10.1080/10428194.2024.2343779. Epub 2024 May 22.
Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641.
Xu W, Yang S, Tam CS, Seymour JF, Zhou K, Opat S, Qiu L, Sun M, Wang T, Trotman J, Pan L, Gao S, Zhou J, Zhou D, Zhu J, Song Y, Hu J, Feng R, Huang H, Su D, Shi M, Li J. Zanubrutinib Monotherapy for Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Pooled Analysis of Three Studies. Adv Ther. 2022 Sep;39(9):4250-4265. doi: 10.1007/s12325-022-02238-7. Epub 2022 Jul 28.
Tam CS, Opat S, Simpson D, Cull G, Munoz J, Phillips TJ, Kim WS, Rule S, Atwal SK, Wei R, Novotny W, Huang J, Wang M, Trotman J. Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma. Blood Adv. 2021 Jun 22;5(12):2577-2585. doi: 10.1182/bloodadvances.2020004074.
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
FG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
FG003
Part 1 and Part 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
FG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
FG0003 subjects
FG0014 subjects
FG0025 subjects
FG0034 subjects
FG0041 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0025 subjects
FG0034 subjects
FG0041 subjects
Type
Comment
Reasons
Sponsor decision
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0040 subjects
Death
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2: Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003274 subjects
FG00494 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003274 subjects
FG004
Type
Comment
Reasons
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
BG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
BG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
BG003
Part 1 and Part 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
BG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0025
BG003278
BG00495
BG005385
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
BG00062.7± 9.45
BG00162.3± 14.38
BG00272.6± 8.88
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0002
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1 and Part 2: Number of Participants With Adverse Events
Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements
The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Posted
Count of Participants
Participants
No
Up to approximately 6 years and 7 months
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Parts 1 and 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Parts 1 and 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG003
Title
Denominators
Categories
At least one treatment-emergent adverse event
Title
Measurements
OG0003
OG0014
OG0025
OG003
Primary
Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib
RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD
The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Posted
Number
milligrams
Month 9
ID
Title
Description
OG000
Part 1: Zanubrutinib
Five dose regimens of zanubrutinib (40 mg QD, 80 mg QD, 160 mg QD, 160 mg BID, and 320 mg QD) were evaluated.
Units
Counts
Participants
OG00017
Secondary
Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib
The pharmacokinetic (PK) analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliters*hour
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Parts 1 and 2: 160 mg BID
Secondary
Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliters*hour
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter
Week 2 Day 1 pre-dose and 24 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Median
Full Range
Hours
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Median
Full Range
Hours
Week 2 Day 1 pre-dose and 24 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Secondary
Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters/hour
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Apparent Volume of Distribution of Zanubrutinib During the Terminal Phase (Vz/F)
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Part 1 and Part 2: 160 mg BID
Secondary
Part 1 and Part 2: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 6 years and 7 months
ID
Title
Description
OG000
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
Units
Counts
Secondary
Part 1 and Part 2: Complete Response Rate (CRR)
CRR is defined as the percentage of participants who achieve a complete response, as assessed by the investigator. For CLL/SLL, CRR includes CRi or better. For WM, CRR includes very good partial response (VGPR) or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 6 years and 7 months
ID
Title
Description
OG000
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
Units
Counts
Participants
Secondary
Part 1 and Part 2: Partial Response (PR) or Better
PR or better is defined as the percentage of participants who achieve a partial response or better, as assessed by the investigator. For CLL/SLL, includes PR, nPR, CRi, CR and for WM includes PR, VGPR, and CR. Efficacy results are reported for the B-cell malignancy subtypes chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and Waldenström macroglobulinemia (WM).
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 6 years and 7 months
ID
Title
Description
OG000
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
Units
Counts
Participants
OG000
Secondary
Part 1 and Part 2: Progression-free Survival (PFS)
PFS is defined as the time from the first dose date of study drug to the date of the earliest occurrence of progressive disease or death due to any cause, whichever occurs first. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Posted
Median
95% Confidence Interval
Months
Up to 6 years and 7 months
ID
Title
Description
OG000
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
Units
Counts
Participants
Secondary
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from the date of the first dose to death due to any cause. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Posted
Median
95% Confidence Interval
Months
Up to 6 years and 7 months
ID
Title
Description
OG000
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
Units
Counts
Participants
OG000
Secondary
Part 1 and Part 2: Duration of Response (DOR)
DOR for responders is defined as time from the date of the earliest qualifying response to the date of progressive disease or death for any cause, whichever occurs earlier. Efficacy results are reported for responders (defined as PR or better, except CLL/SLL and WM) in each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; PR with lymphocytosis or better), Waldenstrom macroglobulinemia (WM; minor response or better), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
Posted
Median
95% Confidence Interval
Months
Up to 6 years and 7 months
ID
Title
Description
OG000
Part 1 and Part 2: Overall
The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
Units
Counts
Participants
Secondary
Number of Participants With Greater Than 75% Bruton's Tyrosine Kinase (BTK) Occupancy
Number of participants with greater than 75% BTK occupancy of zanubrutinib in peripheral blood mononuclear cells (PBMCs)
Pharmacodynamic analysis set consisted of participants in which PBMCs were collected and evaluable samples were obtained.
Posted
Count of Participants
Participants
No
Week 1 Day 1 (W1D1) predose, W1D1 4 hours, W1D2 24 hours, W1D3 predose, and W2D1 predose
ID
Title
Description
OG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
OG003
Time Frame
Up to 6 years and 7 months
Description
One participant in the 320 mg QD group discontinued the study for Other reasons, as shown in the participant flow section, and subsequently died after study discontinuation. That participant is counted under all-cause mortality in this section.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
1
3
1
3
3
3
EG001
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
2
4
2
4
4
4
EG002
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
2
5
3
5
5
5
EG003
Part 1 and Part 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
76
278
157
278
273
278
EG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
External ear neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Intraductal papillary mucinous neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Lentigo maligna
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Neuroendocrine carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sarcomatoid carcinoma of the lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Skin squamous cell carcinoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma of head and neck
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma of the parotid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Central nervous system lesion
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cerebral infarction
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Depressed level of consciousness
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Embolic stroke
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypoglossal nerve paralysis
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Lethargy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sciatica
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Transient ischaemic attack
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bipolar disorder
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chronic idiopathic pain syndrome
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Delirium
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Delirium tremens
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Delusional disorder, unspecified type
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Calculus bladder
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hydronephrosis
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Renal artery thrombosis
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Renal colic
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Subcapsular renal haematoma
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haematoma
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypertension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Lymphoedema
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Orthostatic hypotension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vasculitis
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events3 affected5 at risk
EG00364 events39 affected278 at risk
EG00416 events8 affected95 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events1 affected5 at risk
EG003
Spontaneous haemorrhage
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bradycardia
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac failure congestive
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Palpitations
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Right ventricular failure
Cardiac disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Ear pain
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blepharitis
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Cataract
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Lacrimation increased
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ocular rosacea
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Periorbital oedema
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vision blurred
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Visual impairment
Eye disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Dental caries
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0016 events2 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0016 events2 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Toothache
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events2 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Influenza like illness
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pain
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral swelling
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sensation of foreign body
General disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Seasonal allergy
Immune system disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bronchitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cat scratch disease
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chest wall abscess
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diverticulitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ear infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Folliculitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Helicobacter infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Herpes simplex reactivation
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Herpes zoster
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Influenza
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Localised infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Nasal herpes
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Onychomycosis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oral herpes
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected5 at risk
EG003
Pneumonia
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events1 affected5 at risk
EG003
Pneumonia bacterial
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Sinusitis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tinea pedis
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Tooth abscess
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0004 events2 affected3 at risk
EG0017 events2 affected4 at risk
EG00210 events2 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
International normalised ratio increased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Neutrophil count decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Serum ferritin decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events1 affected5 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Angiomyolipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Benign ear neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cutaneous T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Burning sensation
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cognitive disorder
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected5 at risk
EG003
Dizziness
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events2 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Lethargy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Memory impairment
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sciatica
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Somnolence
Nervous system disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Depressed mood
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hallucination
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Insomnia
Psychiatric disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Renal colic
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary hesitation
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events1 affected5 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Hypertension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events1 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypotension
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral venous disease
Vascular disorders
meddra 23.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Parts 1 and 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00376
OG00419
Title
Denominators
Categories
Title
Measurements
OG000274.7± 47.8
OG001436.8± 103.5
OG0021480± 53.0
OG0031132± 61.1
OG0042281± 60.5
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00359
OG00418
Title
Denominators
Categories
Title
Measurements
OG000301.1± 51.5
OG001460.0± 100.6
OG0021505± 52.7
OG0031253± 59.0
OG0042538± 47.8
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00376
OG00419
Title
Denominators
Categories
Title
Measurements
OG00086.0± 46.6
OG001125± 77.6
OG002397± 76.1
OG003304± 63.8
OG004566± 65.6
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00377
OG00472
Title
Denominators
Categories
Title
Measurements
OG00075.7± 36.2
OG001169± 50.0
OG002387± 60.7
OG003299± 56.1
OG004533± 55.0
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00376
OG00419
Title
Denominators
Categories
Title
Measurements
OG0001.00(0.50 to 1.98)
OG0012.00(1.17 to 2.00)
OG0021.92(0.93 to 2.08)
OG0032.00(0.83 to 8.00)
OG0042.00(0.72 to 3.08)
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00377
OG00472
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.00 to 2.00)
OG0012.50(1.08 to 3.00)
OG0022.00(1.00 to 3.17)
OG0032.00(0.53 to 6.00)
OG0042.00(0.33 to 6.00)
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00359
OG00418
Title
Denominators
Categories
Title
Measurements
OG0001.94± 28.5
OG0011.97± 29.8
OG0023.87± 24.9
OG0032.73± 60.2
OG0043.30± 61.2
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00361
OG00418
Title
Denominators
Categories
Title
Measurements
OG000133± 51.5
OG001174± 100.6
OG002106± 52.7
OG003128± 59.4
OG004126± 47.8
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG00361
OG00418
Title
Denominators
Categories
Title
Measurements
OG000371± 47.5
OG001494± 78.9
OG002593± 61.6
OG003530± 70.0
OG004600± 97.6
Participants
OG000378
Title
Denominators
Categories
CLL/SLL
ParticipantsOG000125
Title
Measurements
OG00095.2(89.8 to 98.2)
WM
ParticipantsOG00073
Title
Measurements
OG00095.9(88.5 to 99.1)
MCL
ParticipantsOG00057
Title
Measurements
OG00082.5(70.1 to 91.3)
MZL
ParticipantsOG00020
Title
Measurements
OG00085.0(62.1 to 96.8)
FL
ParticipantsOG00033
Title
Measurements
OG00036.4(20.4 to 54.9)
DLBCL
ParticipantsOG00045
Title
Measurements
OG00042.2(27.7 to 57.8)
RT
ParticipantsOG00013
Title
Measurements
OG00061.5(31.6 to 86.1)
HCL
ParticipantsOG00012
Title
Measurements
OG00058.3(27.7 to 84.8)
OG000378
Title
Denominators
Categories
CLL/SLL
ParticipantsOG000125
Title
Measurements
OG00016.8(10.7 to 24.5)
WM
ParticipantsOG00073
Title
Measurements
OG00046.6(34.8 to 58.6)
MCL
ParticipantsOG00057
Title
Measurements
OG00028.1(17.0 to 41.5)
MZL
ParticipantsOG00020
Title
Measurements
OG00020.0(5.7 to 43.7)
FL
ParticipantsOG00033
Title
Measurements
OG00018.2(7.0 to 35.5)
DLBCL
ParticipantsOG00045
Title
Measurements
OG00024.4(12.9 to 39.5)
RT
ParticipantsOG00013
Title
Measurements
OG00015.4(1.9 to 45.4)
HCL
ParticipantsOG00012
Title
Measurements
OG00016.7(2.1 to 48.4)
385
Title
Denominators
Categories
CLL/SLL
ParticipantsOG000125
Title
Measurements
OG00092.0(85.8 to 96.1)
WM
ParticipantsOG00073
Title
Measurements
OG00082.2(71.5 to 90.2)
OG000378
Title
Denominators
Categories
CLL/SLL
ParticipantsOG000125
Title
Measurements
OG00061.4(55.2 to NA)Data not estimable due to insufficient number of participants with events
WM
ParticipantsOG00073
Title
Measurements
OG000NA(48.9 to NA)Data not estimable due to insufficient number of participants with events
MCL
ParticipantsOG00057
Title
Measurements
OG00027.6(15.4 to 45.5)
MZL
ParticipantsOG00020
Title
Measurements
OG000NA(17.1 to NA)Data not estimable due to insufficient number of participants with events
FL
ParticipantsOG00033
Title
Measurements
OG00010.4(7.7 to 22.9)
DLBCL
ParticipantsOG00045
Title
Measurements
OG0004.1(2.1 to 5.6)
RT
ParticipantsOG00013
Title
Measurements
OG00017.3(2.8 to NA)Data not estimable due to insufficient number of participants with events
HCL
ParticipantsOG00012
Title
Measurements
OG000NA(28.7 to NA)Data not estimable due to insufficient number of participants with events
378
Title
Denominators
Categories
CLL/SLL
ParticipantsOG000125
Title
Measurements
OG000NA(NA to NA)Data not estimable due to insufficient number of participants with events
WM
ParticipantsOG00073
Title
Measurements
OG000NA(NA to NA)Data not estimable due to insufficient number of participants with events
MCL
ParticipantsOG00057
Title
Measurements
OG000NA(27.2 to NA)Data not estimable due to insufficient number of participants with events
MZL
ParticipantsOG00020
Title
Measurements
OG000NA(NA to NA)Data not estimable due to insufficient number of participants with events
FL
ParticipantsOG00033
Title
Measurements
OG000NA(37.3 to NA)Data not estimable due to insufficient number of participants with events
DLBCL
ParticipantsOG00045
Title
Measurements
OG00014.7(5.5 to 24.8)
RT
ParticipantsOG00013
Title
Measurements
OG00029.3(4.2 to NA)Data not estimable due to insufficient number of participants with events
HCL
ParticipantsOG00012
Title
Measurements
OG000NA(26.6 to NA)Data not estimable due to insufficient number of participants with events
OG000378
Title
Denominators
Categories
CLL/SLL
ParticipantsOG000125
Title
Measurements
OG00058.6(52.6 to NA)Data not estimable due to insufficient number of participants with events
WM
ParticipantsOG00073
Title
Measurements
OG000NA(31.34 to NA)Data not estimable due to insufficient number of participants with events
MCL
ParticipantsOG00057
Title
Measurements
OG00028.2(16.2 to NA)Data not estimable due to insufficient number of participants with events
MZL
ParticipantsOG00020
Title
Measurements
OG000NA(6.5 to NA)Data not estimable due to insufficient number of participants with events
FL
ParticipantsOG00033
Title
Measurements
OG000NA(8.3 to NA)Data not estimable due to insufficient number of participants with events
DLBCL
ParticipantsOG00045
Title
Measurements
OG00014.2(2.8 to 26.2)
RT
ParticipantsOG00013
Title
Measurements
OG00025.9(5.9 to NA)Data not estimable due to insufficient number of participants with events
HCL
ParticipantsOG00012
Title
Measurements
OG000NA(NA to NA)Data not estimable due to insufficient number of participants with events
Part 1 and Part 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
OG004
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.