A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Pa... | NCT03734016

NCT03734016

ID	Type	Description	Link
2018-001366-42	EudraCT Number
CTR20190098	Registry Identifier	ChinaDrugTrials.org

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zanubrutinib	Experimental	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.	Drug: Zanubrutinib
Ibrutinib	Active Comparator	Participants received Ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.	Drug: Ibrutinib

Name	Type	Description	Arm Group Labels	Other Names
Zanubrutinib	Drug	160 mg orally twice daily	Zanubrutinib	BGB-3111

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR) Assessed by the Investigator	ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.	From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
ORR Assessed by the Independent Review Committee (IRC)	ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) assessed by a blinded independent review committee. Overall response was assessed by the IRC for the purpose of regulatory filing with the Food and Drug Administration (FDA). Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.	From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Assessed by the Investigator	PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.	From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

Eligibility Module

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Carti Cancer Center		Little Rock	Arkansas	72205	United States
David Geffen School of Medicine At UCLA

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36511784	Background	Brown JR, Eichhorst B, Hillmen P, Jurczak W, Kazmierczak M, Lamanna N, O'Brien SM, Tam CS, Qiu L, Zhou K, Simkovic M, Mayer J, Gillespie-Twardy A, Ferrajoli A, Ganly PS, Weinkove R, Grosicki S, Mital A, Robak T, Osterborg A, Yimer HA, Salmi T, Wang MD, Fu L, Li J, Wu K, Cohen A, Shadman M. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2023 Jan 26;388(4):319-332. doi: 10.1056/NEJMoa2211582. Epub 2022 Dec 13.
36395435

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Zanubrutinib	Participants received 160 milligrams (mg) zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
FG001	Ibrutinib

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 3, 2023	Feb 26, 2025

Arm/Group Information

ID	Title	Description
BG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
BG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00067.0(35 to 90) BG00168.0(35 to 89) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000114 BG00193 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG00113 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG00047 BG00144 BG002

Geographic Region

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asia	BG00049 BG00145 BG002

Chromosome 17p Deletion (del[17p]) and TP53 Mutation Status

Deletion 17p is a chromosomal abnormality that occurs when part or all of the short arm of chromosome 17 is lost.

The TP53 gene provides instructions for making a protein called tumor protein p53 (or p53) which acts as a tumor suppressor.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Del(17p) and/or TP53 mutation	BG00075 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Response Rate (ORR) Assessed by the Investigator

Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.

Intent To Treat (ITT) Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units	Counts
Participants	OG000327 OG001325

Title

Denominators

Categories

Title	Measurements
	OG00083.5(79.0 to 87.3) OG00174.2(69.0 to 78.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified Wald test	Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)	<0.0001		Response ratio	1.12			2-Sided	95	1.04	1.22			Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.		Non-Inferiority	Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.

Primary

ORR Assessed by the Independent Review Committee (IRC)

ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) assessed by a blinded independent review committee. Overall response was assessed by the IRC for the purpose of regulatory filing with the Food and Drug Administration (FDA).

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Secondary

Progression-free Survival (PFS) Assessed by the Investigator

PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

ITT Analysis Set

Posted

Median

95% Confidence Interval

months

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units	Counts
Participants

Secondary

Progression-free Survival Assessed by the Independent Review Committee

PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Intent To Treat Analysis Set

Posted

Median

95% Confidence Interval

months

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units	Counts
Participants

Secondary

Percentage of Participants With Atrial Fibrillation or Atrial Flutter

Participants were considered as having an atrial fibrillation/flutter event if they had a treatment-emergent AE of either "atrial fibrillation" or "atrial flutter".

The Safety Analysis Set includes all participants who received any dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units	Counts
Participants

Secondary

Duration of Response Assessed by the Independent Review Committee

DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by independent central review. Median DOR was estimated using the Kaplan-Meier method.

Participants in the ITT Analysis Set with an objective response assessed by the IRC

Posted

Median

95% Confidence Interval

months

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units

Secondary

Duration of Response (DOR) Assessed by the Investigator

DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by investigator assessment. Median DOR was estimated using the Kaplan-Meier method.

Participants in the ITT Analysis Set with an objective response as assessed by the investigator

Posted

Median

95% Confidence Interval

months

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units

Secondary

Time to Treatment Failure

Time to treatment failure is defined as the time from randomization to discontinuation of study drug due to any reason. Median time to treatment failure was estimated by the Kaplan-Meier method.

ITT Analysis Set

Posted

Median

95% Confidence Interval

months

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units	Counts
Participants

Secondary

Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Independent Review Committee

The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or a complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis assessed by the blinded IRC.

Disease response was assessed per iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and per Lugano classification for participants with SLL.

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Secondary

Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Investigator

The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis as assessed by the investigator.

Disease response was assessed according to the iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and in accordance with Lugano classification for participants with SLL.

Partial response with lymphocytosis: blood lymphocytes decreased < 50% or increased from baseline, and otherwise meeting criteria for PR.

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Secondary

Overall Survival (OS)

Overall survival is defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.

ITT Analysis Set

Posted

Median

95% Confidence Interval

months

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Units	Counts
Participants

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.

Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline and Weeks 24 and 48

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib

Secondary

Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores in symptom scales indicate better quality of life.

Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline and Weeks 24 and 48

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Secondary

Change From Baseline in European Quality of Life 5-dimensions 5-levels Health Questionnaire (EQ-5D-5L) Visual Analog Scale (VAS)

The EQ-5D-5L VAS measures a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

Participants in the ITT Analysis Set who completed the EQ-5D-5L VAS at Baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point.

Posted

Mean

Standard Deviation

score on a scale

Baseline and Weeks 24 and 48

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAE)

An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.

A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:

Resulted in death
Was life-threatening
Required hospitalization or prolongation of existing hospitalization
Resulted in disability/incapacity
Resulted in a congenital anomaly/birth defect
Was considered a significant medical AE by the investigator based on medical judgment

The Safety Analysis Set includes all participants who received any dose of study drug.

Posted

Count of Participants

Participants

From first dose of study drug up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.

ID	Title	Description
OG000	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
OG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

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	Zanubrutinib	Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.	69	327	172	324	310	324
EG001	Ibrutinib	Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.	83	325	196	324	314	324

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0008 events5 affected324 at risk EG0014 events4 affected324 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events2 affected324 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Hypoglobulinaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events2 affected324 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events2 affected324 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events2 affected324 at risk
Splenic haematoma	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events1 affected324 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Angina unstable	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected324 at risk EG00111 events11 affected324 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events2 affected324 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0013 events3 affected324 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0012 events1 affected324 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Dilated cardiomyopathy	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0014 events3 affected324 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Right ventricular failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0005 events1 affected324 at risk EG0010 events0 affected324 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Bronchogenic cyst	Congenital, familial and genetic disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Cataract	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Cataract nuclear	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Keratitis	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Periorbital oedema	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected324 at risk EG0010 events0 affected324 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0014 events3 affected324 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events2 affected324 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events3 affected324 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Mesenteric panniculitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Noninfective sialoadenitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Catheter site haematoma	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected324 at risk EG0013 events3 affected324 at risk
Drug withdrawal syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected324 at risk EG0010 events0 affected324 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0011 events1 affected324 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0016 events5 affected324 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Jaundice	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Anal abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Appendicitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Arthritis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events2 affected324 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Bacterial sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0011 events1 affected324 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events3 affected324 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00035 events28 affected324 at risk EG00127 events20 affected324 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00044 events33 affected324 at risk EG00135 events22 affected324 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected324 at risk EG0011 events1 affected324 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Dacryocystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Encephalitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Encephalomyelitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Erysipelas	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Fungal abscess central nervous system	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Gastritis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Haematoma infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Hepatitis B	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0013 events3 affected324 at risk
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected324 at risk EG0012 events2 affected324 at risk
Infective tenosynovitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0013 events2 affected324 at risk
Keratitis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Keratitis fungal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Large intestine infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Localised infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected324 at risk EG0011 events1 affected324 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Lymphadenitis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Mastoiditis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Meningitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Meningitis aseptic	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Orchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Otitis externa	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Otitis media acute	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Paronychia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events2 affected324 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00039 events24 affected324 at risk EG00147 events33 affected324 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events2 affected324 at risk EG0012 events2 affected324 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected324 at risk EG0010 events0 affected324 at risk
Pneumonia fungal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0012 events1 affected324 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pneumonia legionella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events1 affected324 at risk
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected324 at risk EG0011 events1 affected324 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Pneumonia viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected324 at risk EG0011 events1 affected324 at risk
Post procedural infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events4 affected324 at risk EG0014 events3 affected324 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events2 affected324 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0010 events0 affected324 at risk
Skin bacterial infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Soft tissue infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0011 events1 affected324 at risk
Sporotrichosis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events2 affected324 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Tick-borne viral encephalitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0012 events2 affected324 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected324 at risk EG00113 events10 affected324 at risk
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0010 events0 affected324 at risk
Wound infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0012 events2 affected324 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Traumatic ulcer	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Blood bilirubin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
False positive investigation result	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected324 at risk EG0010 events0 affected324 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 events2 affected324 at risk EG0012 events1 affected324 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0015 events1 affected324 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0013 events2 affected324 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0015 events2 affected324 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Water intoxication	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0010 events0 affected324 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0013 events2 affected324 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected324 at risk EG0012 events1 affected324 at risk
Atypical fibroxanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0005 events3 affected324 at risk EG0011 events1 affected324 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Chromophobe renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected324 at risk EG0010 events0 affected324 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Laryngeal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events2 affected324 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Mucoepidermoid carcinoma of salivary gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Neuroendocrine carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Oral haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected324 at risk EG0011 events1 affected324 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Skin squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected324 at risk EG0013 events3 affected324 at risk
Superficial spreading melanoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Thymoma malignant recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Central nervous system haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0010 events0 affected324 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0013 events2 affected324 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected324 at risk EG0012 events1 affected324 at risk
Dysarthria	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Epilepsy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected324 at risk EG0012 events2 affected324 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events3 affected324 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0012 events2 affected324 at risk
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Suicidal behaviour	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0015 events3 affected324 at risk
Bladder dysplasia	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected324 at risk EG0010 events0 affected324 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0013 events2 affected324 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events1 affected324 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Pelvic organ prolapse	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Vulva cyst	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected324 at risk EG0013 events3 affected324 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events1 affected324 at risk EG0010 events0 affected324 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected324 at risk EG0012 events2 affected324 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0012 events1 affected324 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0011 events1 affected324 at risk
Pulmonary necrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0014 events3 affected324 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Haematoma	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0012 events2 affected324 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG0011 events1 affected324 at risk
Hypertensive crisis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected324 at risk EG0010 events0 affected324 at risk
Varicose vein	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected324 at risk EG0011 events1 affected324 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00082 events53 affected324 at risk EG001122 events56 affected324 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00010 events6 affected324 at risk EG00113 events11 affected324 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000195 events81 affected324 at risk EG001162 events73 affected324 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00090 events34 affected324 at risk EG00192 events35 affected324 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00027 events22 affected324 at risk EG00169 events45 affected324 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0007 events6 affected324 at risk EG00110 events10 affected324 at risk
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00019 events13 affected324 at risk EG00116 events14 affected324 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00010 events8 affected324 at risk EG00115 events12 affected324 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected324 at risk EG0016 events6 affected324 at risk
Cataract	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00022 events18 affected324 at risk EG00110 events10 affected324 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00032 events20 affected324 at risk EG00123 events21 affected324 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00018 events14 affected324 at risk EG0017 events7 affected324 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00030 events24 affected324 at risk EG00131 events27 affected324 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000106 events61 affected324 at risk EG001158 events83 affected324 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00027 events25 affected324 at risk EG00132 events23 affected324 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00022 events15 affected324 at risk EG00119 events17 affected324 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected324 at risk EG00111 events10 affected324 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00047 events29 affected324 at risk EG00138 events32 affected324 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00017 events11 affected324 at risk EG00118 events11 affected324 at risk
Toothache	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected324 at risk EG0019 events6 affected324 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00025 events22 affected324 at risk EG00135 events29 affected324 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG00030 events21 affected324 at risk EG00116 events13 affected324 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected324 at risk EG00110 events10 affected324 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00043 events36 affected324 at risk EG00157 events49 affected324 at risk
Influenza like illness	General disorders	MedDRA 26.0	Systematic Assessment	EG00028 events10 affected324 at risk EG00110 events7 affected324 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG00027 events24 affected324 at risk EG00131 events24 affected324 at risk
Peripheral swelling	General disorders	MedDRA 26.0	Systematic Assessment	EG00015 events14 affected324 at risk EG00130 events26 affected324 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00044 events35 affected324 at risk EG00150 events37 affected324 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG00013 events12 affected324 at risk EG00113 events12 affected324 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00022 events19 affected324 at risk EG00134 events26 affected324 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG000163 events121 affected324 at risk EG001105 events84 affected324 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00018 events13 affected324 at risk EG00120 events15 affected324 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00015 events12 affected324 at risk EG00116 events13 affected324 at risk
Conjunctivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00010 events7 affected324 at risk EG00120 events15 affected324 at risk
Ear infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00012 events10 affected324 at risk EG0015 events4 affected324 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00010 events10 affected324 at risk EG0016 events6 affected324 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00012 events11 affected324 at risk EG00114 events10 affected324 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00016 events12 affected324 at risk EG00114 events12 affected324 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00026 events20 affected324 at risk EG00123 events16 affected324 at risk
Oral herpes	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0009 events4 affected324 at risk EG00117 events13 affected324 at risk
Paronychia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected324 at risk EG00111 events11 affected324 at risk
Pharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events6 affected324 at risk EG00118 events12 affected324 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00047 events33 affected324 at risk EG00157 events37 affected324 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00020 events16 affected324 at risk EG0018 events7 affected324 at risk
Rhinitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected324 at risk EG00111 events10 affected324 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00026 events20 affected324 at risk EG00119 events16 affected324 at risk
Skin infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected324 at risk EG00116 events13 affected324 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG000155 events95 affected324 at risk EG001105 events64 affected324 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00068 events35 affected324 at risk EG00158 events31 affected324 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00062 events49 affected324 at risk EG00144 events38 affected324 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00019 events16 affected324 at risk EG00127 events23 affected324 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00012 events12 affected324 at risk EG0016 events6 affected324 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00020 events12 affected324 at risk EG00129 events20 affected324 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00012 events7 affected324 at risk EG00123 events16 affected324 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0008 events5 affected324 at risk EG00115 events10 affected324 at risk
Blood bilirubin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00014 events8 affected324 at risk EG00120 events11 affected324 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00036 events18 affected324 at risk EG00121 events12 affected324 at risk
Blood pressure increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00019 events6 affected324 at risk EG00127 events12 affected324 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00014 events10 affected324 at risk EG00116 events11 affected324 at risk
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00075 events26 affected324 at risk EG00169 events24 affected324 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00040 events11 affected324 at risk EG00147 events20 affected324 at risk
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00027 events22 affected324 at risk EG00120 events14 affected324 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00012 events12 affected324 at risk EG00123 events22 affected324 at risk
Gout	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00010 events4 affected324 at risk EG00116 events10 affected324 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00021 events13 affected324 at risk EG0018 events8 affected324 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00037 events16 affected324 at risk EG00137 events22 affected324 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00039 events24 affected324 at risk EG00139 events24 affected324 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00018 events10 affected324 at risk EG00113 events8 affected324 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00015 events14 affected324 at risk EG0013 events3 affected324 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00069 events54 affected324 at risk EG00185 events63 affected324 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00026 events26 affected324 at risk EG00130 events26 affected324 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00010 events10 affected324 at risk EG00112 events10 affected324 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00018 events13 affected324 at risk EG00151 events42 affected324 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00013 events11 affected324 at risk EG00114 events14 affected324 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected324 at risk EG00114 events12 affected324 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00030 events26 affected324 at risk EG00130 events26 affected324 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG00018 events11 affected324 at risk EG00140 events17 affected324 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG00021 events14 affected324 at risk EG00123 events15 affected324 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00039 events32 affected324 at risk EG00128 events26 affected324 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00036 events29 affected324 at risk EG00146 events35 affected324 at risk
Paraesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected324 at risk EG00112 events10 affected324 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00014 events11 affected324 at risk EG0019 events8 affected324 at risk
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected324 at risk EG00122 events14 affected324 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00027 events25 affected324 at risk EG00128 events26 affected324 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00023 events18 affected324 at risk EG00120 events13 affected324 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00059 events46 affected324 at risk EG00155 events43 affected324 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00019 events16 affected324 at risk EG00116 events13 affected324 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00046 events27 affected324 at risk EG00145 events24 affected324 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00014 events12 affected324 at risk EG00110 events10 affected324 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00018 events17 affected324 at risk EG00112 events11 affected324 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00016 events8 affected324 at risk EG00115 events12 affected324 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected324 at risk EG00112 events11 affected324 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected324 at risk EG00110 events9 affected324 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00041 events32 affected324 at risk EG00119 events19 affected324 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00032 events24 affected324 at risk EG00110 events9 affected324 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00069 events38 affected324 at risk EG00158 events44 affected324 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00015 events12 affected324 at risk EG00110 events7 affected324 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00012 events8 affected324 at risk EG00113 events12 affected324 at risk
Haematoma	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00023 events17 affected324 at risk EG00117 events14 affected324 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG000154 events82 affected324 at risk EG001155 events74 affected324 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected324 at risk EG00111 events11 affected324 at risk

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D012008	Recurrence

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms