Study of Ibrutinib Combined With Venetoclax in Subjects W... | NCT03112174

NCT03112174

ID	Type	Description	Link
2017-000129-12	EudraCT Number

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Safety Run-in	Experimental	Participants with a low or high risk of TLS enroll into the open-label Safety Run-in Period to receive concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramp up to a target dose of 400 mg once daily over a 5-week period.	Drug: Ibrutinib Drug: Venetoclax
Randomization Phase: Ibrutinb + Venetoclax	Experimental	Participants randomized to ibrutinib and venetoclax for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax is discontinued after 104 weeks of treatment, regardless of response assessment.	Drug: Ibrutinib Drug: Venetoclax
Randomization Phase: Ibrutinib + Placebo	Placebo Comparator	Participants randomized to ibrutinib and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo is discontinued after 104 weeks of treatment, regardless of response assessment.	Drug: Ibrutinib Drug: Placebo Oral tablet to match Venetoclax
Treatment-naive Open-label Arm	Experimental	Participants are treated with ibrutinib 560 mg and venetoclax 400 mg, administered using the 5-week ramp-up schedule.	Drug: Ibrutinib Drug: Venetoclax

Name	Type	Description	Arm Group Labels	Other Names
Ibrutinib	Drug	Administered orally once daily	Randomization Phase: Ibrutinb + Venetoclax Randomization Phase: Ibrutinib + Placebo Safety Run-in

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in)	TLS events are defined as follows: Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions: For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine > 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS. In participants with renal dysfunction at baseline (CrCl < 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, cardiac dysrhythmia, or death. Laboratory TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) for laboratory TLS, that does not resolve within 72 hours despite protocol required management.	After at least 3 months of treatment, with an overall median treatment duration of 20.0 months
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)	DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications: Non-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting >5 days; Gr 3 fatigue persisting >7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug >7 days for toxicity. Hematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC <500/mm^3) lasting for > 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (<25,000/mm^3) that persists for > 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug >7 days for hematologic toxicity.	After at least 3 months of treatment, with an overall median treatment duration of 20.0 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)	AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) (Safety Run-in)	OS is defined as the time from the date of the first dose of study treatment to death from any cause.	For an overall median time on study of 74.78 months
Progression-free Survival (PFS) (Safety Run-in)

Eligibility Module

Eligibility Criteria

Relapsed/Refractory Arm

Inclusion Criteria:

Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
At least 1 measurable site of disease on cross-sectional imaging (CT).
At least 1, but no more than 5, prior treatment regimens for MCL.
Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
Subjects must have adequate fresh or paraffin embedded tissue.
Adequate hematologic, hepatic and renal function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.

Exclusion Criteria:

History or current evidence of central nervous system lymphoma.
Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors.
Prior treatment with venetoclax or other BCL2 inhibitors.
Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents <= 21 days prior to receiving the first dose of study drug.
Treatment with any of the following within 7 days prior to the first dose of study drug: moderate to strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers.

Treatment Naïve Arm

Inclusion Criteria:

Pathologically confirmed treatment-naive MCL (tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
Men and women ≥18 years of age with a TP53 mutation.
At least 1 measurable site of disease by CT.
Must have adequate fresh or paraffin-embedded tissue.
Eastern Cooperative Oncology Group (ECOG) performance status score 0 to <= 2.
Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

Blastoid variant of MCL
History or current evidence of CNS lymphoma.
Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors.
Prior treatment with venetoclax or other BCL2 inhibitors.
Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug.
Any uncontrolled active systemic infection.
Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
History of HIV or active HCV or HBV.
Major surgery within 4 weeks of the first dose of study drug.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk.
Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
Treatment with any of the following within 7 days prior to the first dose of study drug: Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or moderate or strong CYP3A inducers.
Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with known risk factors (as defined by high tumor burden and/or diminished renal function, as detailed in "Study Design" section above) for TLS.
Chronic liver disease with hepatic impairment Child-Pugh class B or C.
Unwilling or unable to participate in all required study evaluations and procedures.
Known hypersensitivity to the active ingredient or other components of one or more study drugs.

Facility	Status	City	State	ZIP	Country	Contacts
The University of Arizona Cancer Centre-North Campus		Tucson	Arizona	85719	United States
City of Hope

PubMed Identifier	Type	Citation	Retractions
39914418	Derived	Wang M, Jurczak W, Trneny M, Belada D, Wrobel T, Ghosh N, Keating MM, van Meerten T, Alvarez RF, von Keudell G, Thieblemont C, Peyrade F, Andre M, Hoffmann M, Szafer-Glusman E, Lin J, Dean JP, Neuenburg JK, Tam CS. Ibrutinib plus venetoclax in relapsed or refractory mantle cell lymphoma (SYMPATICO): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2025 Feb;26(2):200-213. doi: 10.1016/S1470-2045(24)00682-X.
34717692

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
FG001

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	Sep 16, 2022	Jun 10, 2025

Arm/Group Information

ID	Title	Description
BG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
BG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
BG002	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
BG003	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
BG004	Treatment-naive Open-label Arm	Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
BG005	Total	Total of all reporting groups

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

Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in)

TLS events are defined as follows:

Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions:
- For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine > 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS.
- In participants with renal dysfunction at baseline (CrCl < 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, cardiac dysrhythmia, or death.
Laboratory TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) for laboratory TLS, that does not resolve within 72 hours despite protocol required management.

All treated safety run-in participants

Posted

Count of Participants

Participants

After at least 3 months of treatment, with an overall median treatment duration of 20.0 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
OG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Units	Counts
Participants	OG00015 OG0016

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010

Primary

Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)

DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications:

Non-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting >5 days; Gr 3 fatigue persisting >7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug >7 days for toxicity.

Hematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC <500/mm^3) lasting for > 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (<25,000/mm^3) that persists for > 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug >7 days for hematologic toxicity.

All treated safety run-in participants

Posted

Count of Participants

Participants

After at least 3 months of treatment, with an overall median treatment duration of 20.0 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)

AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).

All treated safety run-in participants

Posted

Count of Participants

Participants

From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 20.0 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
OG001	Safety Run-in: Low TLS Risk at Baseline

Primary

Progression-free Survival (PFS) (Randomization Phase)

PFS is defined as the time from the date of randomization to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.

All randomized participants

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 61.34 months

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Units	Counts

Primary

Complete Response (CR) Rate (Treatment-Naive Arm)

CR rate is defined as the percentage of participants with a CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).

All Enrolled Treatment-Naïve Participants

Posted

Number

95% Confidence Interval

percentage of participants

For an overall median time on study of 40.51 months

ID	Title	Description
OG000	Treatment-naive Open-label Arm	Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) (Safety Run-in)

OS is defined as the time from the date of the first dose of study treatment to death from any cause.

All Enrolled Safety Run-in participants

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 74.78 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
OG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Units	Counts
Participants

Secondary

Progression-free Survival (PFS) (Safety Run-in)

PFS is defined as the time from the date of the first dose of study treatment to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.

All Enrolled Safety Run-in participants

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 74.78 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
OG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Units	Counts
Participants

Secondary

Duration of Response (DOR) (Safety Run-in)

DOR is defined for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma [Cheson 2014]) to disease progression or death, whichever occurs first.

All Enrolled Safety Run-in Subjects Achieving Response (Partial Response or Better)

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 74.78 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
OG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Units	Counts

Secondary

Overall Response Rate (ORR) (Safety Run-in)

ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).

All enrolled Safety Run-in participants

Posted

Number

95% Confidence Interval

percentage of participants

For an overall median time on study of 74.78 months

ID	Title	Description
OG000	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
OG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Units	Counts
Participants

Secondary

Percentage of Participants With a Complete Response (CR) (Randomization Phase)

Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).

All randomized participants

Posted

Number

95% Confidence Interval

percentage of participants

For an overall median time on study of 61.34 months

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Units	Counts

Secondary

Overall Response Rate (ORR) (Randomization Phase and Treatment-Naive Arm)

ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).

All randomized participants and all treatment-naive open-label arm participants.

Posted

Number

95% Confidence Interval

percentage of participants

For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
OG002	Treatment-naive Open-label Arm

Secondary

MRD-negative Remission Rate in Participants Who Achieve CR Per Investigator Assessment (Randomization Phase and Treatment-Naive Arm)

MRD-negative remission rate is defined as the percentage of participants with undetectable MRD at documented CR in participants who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.

All enrolled treatment-naïve participants achieving CR who were evaluable for MRD (those who had positive MRD status at screening). Participants with a given post-screening sample.

Posted

Number

95% Confidence Interval

percentage of participants

For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Overall Survival (OS) (Randomization Phase and Treatment-Naive Arm)

OS is defined as the time from the date of randomization (Randomization Phase) or the first dose of study treatment (Treatment-Naïve arm) to death from any cause.

All randomized and all enrolled treatment-naïve participants

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
OG002	Treatment-naive Open-label Arm

Secondary

Duration of Response (DOR) (Randomization Phase and Treatment-Naive Arm)

DOR is defined as the time frame for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma [Cheson 2014]) to disease progression or death, whichever occurs first.

All randomized participants and all enrolled treatment-naïve participants achieving response (partial response or better)

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Time to Next Treatment (TTNT) (Randomization Phase and Treatment-Naive Arm)

TTNT is defined as the duration from the date of randomization (Randomization Phase) or date of first dose of study treatment (Treatment-Naive Arm) to the start date of any anti-lymphoma treatment subsequent to study treatment. Post-treatment stem cell transplantation, chimeric antigen receptor (CAR) T-cell therapy, or other cellular therapies were not considered subsequent anti-cancer treatments for participants responding to the study treatment (CR or PR).

All randomized and all enrolled treatment-naïve participants

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Number of Participants With TEAEs (Randomization Phase)

All randomized and treated participants

Posted

Count of Participants

Participants

From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 19.5 months

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001

Secondary

Number of Participants With TLS TEAEs (Randomization Phase)

Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug (SD). Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).

All randomized and treated participants

Posted

Count of Participants

Participants

From first dose of study drug until the end of treatment + 7 days, with an overall median treatment duration 19.5 months

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State Pharmacokinetics (PK) of Ibrutinib: Maximum Observed Plasma Concentration (Cmax) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

ng/mL

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Time to Cmax (Tmax) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Median

Full Range

hours

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

ng·h/mL

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Terminal Elimination Half-Life (t1/2,Term) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

hours

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Time of Last Measurable Concentration (Tlast) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Median

Full Range

hours

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From 0-24 Hours (AUC0-24) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

ng·h/mL

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Terminal Elimination Rate Constant (λz) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

1/hour

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Ibrutinib: Apparent Total Clearance at Steady State (CLss/F) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

L/hour

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Steady-State PK of Venetoclax: Cmax (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants receiving venetoclax with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

ng/mL

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.

Units	Counts
Participants	OG000

Secondary

Steady-State PK of Venetoclax: AUC0-24 (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants receiving venetoclax with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

ng·h/mL

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.

Units	Counts
Participants	OG000

Secondary

Steady-State PK of Venetoclax: Time to Cmax (Tmax) (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants receiving venetoclax with an evaluable PK assessment at given time point.

Posted

Median

Full Range

hours

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.

Units	Counts
Participants	OG000

Secondary

Steady-State PK of Venetoclax: CLss/F (Randomization Phase)

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Participants receiving venetoclax with an evaluable PK assessment at given time point.

Posted

Mean

Standard Deviation

L/hour

Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.

Units	Counts
Participants	OG000

Secondary

Time to Worsening in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale of the Health-related Quality of Life (Randomization Phase)

The FACT-Lym lymphoma-specific additional concerns subscale responses to all items are rated on a 5-point scale ranging from 0 "not at all" to 4 "very much". The lymphoma subscale includes 15 items and scores range from 0 to 60, with higher scores representing better functional status and well-being. A 5-point change in the Lym subscale was selected as a conservative estimate of clinically meaningful deterioration in lymphoma symptoms.

All randomized participants

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 61.34 months (Randomization Phase)

ID	Title	Description
OG000	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
OG001	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

Secondary

Duration of CR (Treatment-Naive Arm)

Duration of CR, defined for subjects who achieve CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014) as the time from the first occurrence of CR to disease progression or death, whichever occurs first.

All Enrolled Treatment-Naïve Subjects Achieving CR

Posted

Median

95% Confidence Interval

months

For an overall median time on study of 40.51 months

ID	Title	Description
OG000	Treatment-naive Open-label Arm	Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).

Units	Counts
Participants	OG000

Secondary

Progression-free Survival (PFS) (Treatment-Naive Arm)

All enrolled treatment-naïve participants

Posted

Median

Full Range

months

For an overall median time on study of 40.51 months

ID	Title	Description
OG000	Treatment-naive Open-label Arm	Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).

Units	Counts
Participants	OG000

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	Safety Run-in: Increased TLS Risk at Baseline	Participants with an increased risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.	8	15	15	15	15	15
EG001	Safety Run-in: Low TLS Risk at Baseline	Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.	3	6	3	6	6	6
EG002	Randomization Phase: Ibrutinb + Venetoclax	Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.	70	134	92	134	131	134
EG003	Randomization Phase: Ibrutinib + Placebo	Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.	78	132	86	132	127	132
EG004	Treatment-naive Open-label Arm	Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).	20	78	48	78	77	78

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0027 events6 affected134 at risk EG0032 events2 affected132 at risk EG0040 events0 affected78 at risk
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0025 events2 affected134 at risk EG003
SPONTANEOUS HAEMORRHAGE	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00210 events4 affected134 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0027 events6 affected134 at risk EG003
ATRIAL FLUTTER	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0025 events5 affected134 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
MITRAL VALVE DISEASE	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0023 events2 affected134 at risk EG003
PERICARDITIS	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CATARACT	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
UVEITIS	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
GASTRIC ULCER PERFORATION	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
GINGIVAL BLEEDING	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PNEUMATOSIS INTESTINALIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PROCTITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SUBILEUS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ASTHENIA	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CARDIAC DEATH	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CHEST PAIN	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
DEATH	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
FATIGUE	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
MALAISE	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PYREXIA	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
SEROSITIS	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SUDDEN DEATH	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
BILIARY COLIC	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CHOLANGITIS	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0024 events3 affected134 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
GRAFT VERSUS HOST DISEASE	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ABSCESS LIMB	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BACTERAEMIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
BACTERIAL SEPSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
CENTRAL NERVOUS SYSTEM INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG00210 events6 affected134 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0027 events5 affected134 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
DISSEMINATED CRYPTOCOCCOSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
EMPYEMA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
FUNGAL ABSCESS CENTRAL NERVOUS SYSTEM	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
MEDIASTINITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
NECROTISING FASCIITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ORCHITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PERIORBITAL CELLULITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PERITONITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected6 at risk EG00226 events17 affected134 at risk EG003
PNEUMONIA ASPIRATION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PNEUMONIA CHLAMYDIAL	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PNEUMONIA MORAXELLA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PNEUMONIA VIRAL	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PULMONARY SEPSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
SEPSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SKIN INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
TOOTH INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
VIRAL INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
VIRAL PHARYNGITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
WOUND SEPSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0027 events7 affected134 at risk EG003
CRANIOCEREBRAL INJURY	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0024 events2 affected134 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
GOUT	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events4 affected134 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
POLYARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ADRENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BENIGN LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
INTRADUCTAL PROLIFERATIVE BREAST LESION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
MANTLE CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00223 events15 affected134 at risk EG003
MANTLE CELL LYMPHOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
METASTATIC MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
AMNESIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BRADYKINESIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
EPILEPSY	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
INTRAVENTRICULAR HAEMORRHAGE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SEIZURE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SPEECH DISORDER	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
TREMOR	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0026 events3 affected134 at risk EG003
UPPER AIRWAY OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
VOCAL CORD POLYP	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CUTANEOUS VASCULITIS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES	Social circumstances	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
AORTIC ANEURYSM	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
AORTIC STENOSIS	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
EMBOLISM	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ILIAC ARTERY STENOSIS	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00020 events4 affected15 at risk EG0012 events2 affected6 at risk EG00240 events27 affected134 at risk EG00332 events17 affected132 at risk EG00427 events17 affected78 at risk
INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected15 at risk EG0014 events3 affected6 at risk EG00217 events12 affected134 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00253 events12 affected134 at risk EG003
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events2 affected134 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00033 events7 affected15 at risk EG0012 events1 affected6 at risk EG002207 events46 affected134 at risk EG003
SPLENOMEGALY	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SPONTANEOUS HAEMATOMA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0006 events4 affected15 at risk EG0015 events4 affected6 at risk EG00274 events22 affected134 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00214 events12 affected134 at risk EG003
BRADYCARDIA	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events4 affected134 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0028 events5 affected134 at risk EG003
EAR PAIN	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0024 events4 affected134 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0026 events6 affected134 at risk EG003
ASTIGMATISM	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
CATARACT	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0026 events5 affected134 at risk EG003
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
DIPLOPIA	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events1 affected134 at risk EG003
DRY EYE	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected15 at risk EG0013 events2 affected6 at risk EG00225 events18 affected134 at risk EG003
EYE DISCHARGE	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected6 at risk EG0023 events2 affected134 at risk EG003
EYE IRRITATION	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0005 events2 affected15 at risk EG0012 events1 affected6 at risk EG00216 events13 affected134 at risk EG003
EYE PAIN	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00210 events6 affected134 at risk EG003
HYPERMETROPIA	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
LACRIMATION INCREASED	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0016 events2 affected6 at risk EG00230 events18 affected134 at risk EG003
MACULAR DEGENERATION	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
MACULOPATHY	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
OCULAR HYPERAEMIA	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PHOTOPHOBIA	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected15 at risk EG0013 events1 affected6 at risk EG00214 events11 affected134 at risk EG003
PHOTOPSIA	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0028 events5 affected134 at risk EG003
VISION BLURRED	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected15 at risk EG00110 events3 affected6 at risk EG00247 events25 affected134 at risk EG003
VISUAL ACUITY REDUCED	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0011 events1 affected6 at risk EG00242 events20 affected134 at risk EG003
VITREOUS FLOATERS	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events2 affected6 at risk EG0027 events5 affected134 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events4 affected134 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected15 at risk EG0011 events1 affected6 at risk EG00222 events14 affected134 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG0028 events6 affected134 at risk EG003
ANAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events2 affected134 at risk EG003
CHRONIC GASTRITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected15 at risk EG0015 events2 affected6 at risk EG00223 events19 affected134 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00024 events10 affected15 at risk EG00121 events5 affected6 at risk EG002243 events84 affected134 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG0029 events7 affected134 at risk EG003
DUODENITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events2 affected134 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events3 affected6 at risk EG00228 events19 affected134 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0025 events3 affected134 at risk EG003
ENTERITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
FAECES SOFT	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
FEMORAL HERNIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0026 events6 affected134 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0028 events7 affected134 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG00215 events11 affected134 at risk EG003
GLOSSODYNIA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG00210 events7 affected134 at risk EG003
HYPOAESTHESIA ORAL	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected6 at risk EG00215 events11 affected134 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00015 events5 affected15 at risk EG00116 events5 affected6 at risk EG00278 events43 affected134 at risk EG003
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events2 affected134 at risk EG003
PEPTIC ULCER	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0013 events1 affected6 at risk EG00216 events12 affected134 at risk EG003
TONGUE ERYTHEMA	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
TONGUE HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0009 events5 affected15 at risk EG00111 events1 affected6 at risk EG00259 events27 affected134 at risk EG003
ADVERSE DRUG REACTION	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ASTHENIA	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected6 at risk EG00238 events26 affected134 at risk EG003
CATHETER SITE BRUISE	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CHEST PAIN	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0027 events6 affected134 at risk EG003
CHILLS	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events2 affected6 at risk EG0028 events8 affected134 at risk EG003
EXTRAVASATION	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
FATIGUE	General disorders	MedDRA 26.1	Systematic Assessment	EG00012 events5 affected15 at risk EG00112 events4 affected6 at risk EG00266 events39 affected134 at risk EG003
GENERALISED OEDEMA	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
IMPAIRED HEALING	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00211 events10 affected134 at risk EG003
INJECTION SITE BRUISING	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
OEDEMA	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0014 events3 affected6 at risk EG00220 events16 affected134 at risk EG003
PAIN	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
PERIPHERAL SWELLING	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected6 at risk EG00219 events11 affected134 at risk EG003
PYREXIA	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected6 at risk EG00251 events28 affected134 at risk EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0017 events1 affected6 at risk EG00210 events2 affected134 at risk EG003
HEPATITIS CHOLESTATIC	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0027 events3 affected134 at risk EG003
PORTAL FIBROSIS	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
ALLERGY TO ARTHROPOD BITE	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPOGAMMAGLOBULINAEMIA	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG00210 events7 affected134 at risk EG003
CANDIDA INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG00210 events7 affected134 at risk EG003
CONJUNCTIVITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected6 at risk EG00210 events8 affected134 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected15 at risk EG0011 events1 affected6 at risk EG00220 events16 affected134 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
CYSTITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG00113 events1 affected6 at risk EG0023 events2 affected134 at risk EG003
DEMODICIDOSIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
EPIDIDYMITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
FOLLICULITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events3 affected134 at risk EG003
FUNGAL INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00212 events7 affected134 at risk EG003
LOCALISED INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0028 events5 affected134 at risk EG003
NASAL ABSCESS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG00211 events8 affected134 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG00210 events8 affected134 at risk EG003
PARONYCHIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected6 at risk EG0026 events5 affected134 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0027 events7 affected134 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG00211 events6 affected134 at risk EG003
RHINITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
SINUSITIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG00214 events11 affected134 at risk EG003
SKIN CANDIDA	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
TINEA CRURIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected15 at risk EG0012 events1 affected6 at risk EG00242 events23 affected134 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00014 events4 affected15 at risk EG0014 events1 affected6 at risk EG00222 events14 affected134 at risk EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events2 affected134 at risk EG003
VULVOVAGINAL CANDIDIASIS	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events2 affected6 at risk EG0028 events8 affected134 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0006 events4 affected15 at risk EG0011 events1 affected6 at risk EG00211 events11 affected134 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events1 affected134 at risk EG003
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SCRATCH	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0023 events3 affected134 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0026 events5 affected134 at risk EG003
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0013 events1 affected6 at risk EG0024 events4 affected134 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0013 events1 affected6 at risk EG0025 events5 affected134 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events1 affected6 at risk EG0027 events4 affected134 at risk EG003
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0016 events2 affected6 at risk EG0024 events3 affected134 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0006 events3 affected15 at risk EG0013 events2 affected6 at risk EG0028 events7 affected134 at risk EG003
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
BLOOD PHOSPHORUS INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
BLOOD PRESSURE INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0029 events7 affected134 at risk EG003
BLOOD UREA INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
TROPONIN T INCREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected15 at risk EG0010 events0 affected6 at risk EG00217 events15 affected134 at risk EG003
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events1 affected134 at risk EG003
ACIDOSIS	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected15 at risk EG0011 events1 affected6 at risk EG00233 events24 affected134 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG0024 events4 affected134 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0025 events5 affected134 at risk EG003
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0023 events2 affected134 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0013 events1 affected6 at risk EG00212 events9 affected134 at risk EG003
HYPERVOLAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00011 events5 affected15 at risk EG0012 events2 affected6 at risk EG00231 events21 affected134 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0005 events3 affected15 at risk EG0016 events4 affected6 at risk EG00223 events14 affected134 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0023 events2 affected134 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0025 events4 affected134 at risk EG003
IRON DEFICIENCY	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0025 events4 affected134 at risk EG003
VITAMIN B12 DEFICIENCY	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events3 affected15 at risk EG0018 events3 affected6 at risk EG00229 events22 affected134 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected6 at risk EG00218 events12 affected134 at risk EG003
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected6 at risk EG0026 events4 affected134 at risk EG003
LIMB DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events2 affected6 at risk EG00216 events12 affected134 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0027 events6 affected134 at risk EG003
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG00113 events2 affected6 at risk EG00218 events13 affected134 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG00218 events11 affected134 at risk EG003
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
SPONDYLITIS	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG00210 events7 affected134 at risk EG003
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG00121 events3 affected6 at risk EG00222 events16 affected134 at risk EG003
DYSARTHRIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0026 events6 affected134 at risk EG003
DYSKINESIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0014 events3 affected6 at risk EG00219 events15 affected134 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events1 affected6 at risk EG00210 events8 affected134 at risk EG003
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected15 at risk EG0011 events1 affected6 at risk EG0023 events1 affected134 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events1 affected6 at risk EG0029 events5 affected134 at risk EG003
PARESIS	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0024 events4 affected134 at risk EG003
PRESYNCOPE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0011 events1 affected6 at risk EG0022 events2 affected134 at risk EG003
RESTLESS LEGS SYNDROME	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
SCIATICA	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0023 events2 affected134 at risk EG003
SENSORY DISTURBANCE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0027 events6 affected134 at risk EG003
TREMOR	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected6 at risk EG0024 events2 affected134 at risk EG003
VASCULAR ENCEPHALOPATHY	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG0026 events5 affected134 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0023 events3 affected134 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0022 events2 affected134 at risk EG003
DISORIENTATION	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected6 at risk EG00212 events12 affected134 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
BLADDER HYPERTROPHY	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0027 events5 affected134 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected6 at risk EG0025 events4 affected134 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
POLLAKIURIA	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events4 affected134 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0025 events3 affected134 at risk EG003
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events1 affected134 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0023 events2 affected134 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected15 at risk EG0012 events2 affected6 at risk EG00246 events28 affected134 at risk EG003
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected6 at risk EG0024 events4 affected134 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected15 at risk EG0013 events2 affected6 at risk EG00224 events17 affected134 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0017 events2 affected6 at risk EG00214 events9 affected134 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected6 at risk EG0028 events7 affected134 at risk EG003
NASAL DRYNESS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected6 at risk EG00215 events14 affected134 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events4 affected134 at risk EG003
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected6 at risk EG0028 events5 affected134 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0023 events3 affected134 at risk EG003
SINUS DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
UPPER-AIRWAY COUGH SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0024 events3 affected134 at risk EG003
VOCAL CORD POLYP	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG0020 events0 affected134 at risk EG003
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
BLOOD BLISTER	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events1 affected6 at risk EG0021 events1 affected134 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected6 at risk EG0027 events6 affected134 at risk EG003
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected6 at risk EG0028 events7 affected134 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0021 events1 affected134 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG00210 events9 affected134 at risk EG003
ONYCHOCLASIS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG00213 events11 affected134 at risk EG003
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0028 events6 affected134 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected6 at risk EG00218 events15 affected134 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected6 at risk EG0027 events5 affected134 at risk EG003
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0029 events8 affected134 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected15 at risk EG0016 events2 affected6 at risk EG00233 events18 affected134 at risk EG003
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0027 events4 affected134 at risk EG003
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0026 events5 affected134 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected6 at risk EG0022 events2 affected134 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HAEMATOMA	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0020 events0 affected134 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected15 at risk EG0015 events1 affected6 at risk EG00232 events20 affected134 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected6 at risk EG0027 events7 affected134 at risk EG003

ID	Term
D020522	Lymphoma, Mantle-Cell
D008228	Lymphoma, Non-Hodgkin

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases