Ublituximab + TGR-1202 Compared to Obinutuzumab + Chloram... | NCT02612311

ID	Type	Description	Link
2015-005758-36	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Ublituximab + Umbralisib	Experimental	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Biological: Ublituximab Drug: TGR-1202
Arm B: Obinutuzumab + Chlorambucil	Active Comparator	Participants received Obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 15 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with Chlorambucil 0.5 milligram per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Biological: Obinutuzumab Drug: Chlorambucil
Arm C: Ublituximab	Experimental	Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Biological: Ublituximab
Arm D: Umbralisib	Experimental	Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.

Name	Type	Description	Arm Group Labels	Other Names
Obinutuzumab	Biological	Obinutuzumab: IV infusion	Arm B: Obinutuzumab + Chlorambucil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria	PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 centimetres (cm) in the longest diameter (LD) and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 grams per Liter (g/L) decrease from the highest on-study hemoglobin (Hgb).	From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR) Per iwCLL Criteria	ORR=percent of participants who achieve complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR) or nodular partial response (nPR).CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L);Regression of all target nodal masses to ≤1.5cm in LD;Normal spleen,liver size;Regression to normal of all nodal non-target disease and disappearance of all detectable;Non-nodal,non-target disease;Morphologically negative bone marrow;No lymphoid nodules;ANC >1.5x10^9/L,platelets≥100x10^9/L,Hgb≥110 g/L.PR:No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or ≥50% decrease from baseline in sum of products of target nodal lesions;splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;response in any 1: ANC>1.5x10^9/L, platelets>100x10^9/L,Hgb>110g/L or ≥50% increase over baseline in any of these.CRi:for CR except with ANC<1000/µL and/or platelets<100.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
TG Therapeutics Investigational Trial Site		Huntsville	Alabama	35805	United States
TG Therapeutics Investigational Trial Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 20, 2020	Feb 22, 2024

Arm/Group Information

ID	Title	Description
BG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
BG001	Active Comparator: Arm B: Obinutuzumab + Chlorambucil	Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
BG002	Experimental: Arm C: Ublituximab	Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
BG003	Experimental: Arm D: Umbralisib	Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00066.2(39 to 88) BG00167.1(36 to 91) BG00267.6(40 to 88) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00075 BG00167 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0015 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria

PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 centimetres (cm) in the longest diameter (LD) and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 grams per Liter (g/L) decrease from the highest on-study hemoglobin (Hgb).

The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202).

Posted

Median

95% Confidence Interval

Months

From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months)

ID	Title	Description
OG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
OG001	Active Comparator: Arm B: Obinutuzumab + Chlorambucil	Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
OG002	Experimental: Arm C: Ublituximab	Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
OG003	Experimental: Arm D: Umbralisib	Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.

Units	Counts
Participants	OG000210 OG001211 OG00291 OG003

Title

Denominators

Categories

Title	Measurements
	OG00033.2(27.7 to 39.6) OG00117.5(16.6 to 22.6) OG00232.9(19.1 to 45.0) OG003

Secondary

Overall Response Rate (ORR) Per iwCLL Criteria

ORR=percent of participants who achieve complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR) or nodular partial response (nPR).CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L);Regression of all target nodal masses to ≤1.5cm in LD;Normal spleen,liver size;Regression to normal of all nodal non-target disease and disappearance of all detectable;Non-nodal,non-target disease;Morphologically negative bone marrow;No lymphoid nodules;ANC >1.5x10^9/L,platelets≥100x10^9/L,Hgb≥110 g/L.PR:No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or ≥50% decrease from baseline in sum of products of target nodal lesions;splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;response in any 1: ANC>1.5x10^9/L, platelets>100x10^9/L,Hgb>110g/L or ≥50% increase over baseline in any of these.CRi:for CR except with ANC<1000/µL and/or platelets<100.

The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Percentages are rounded off to the nearest decimal point.

Posted

Number

percentage of participants

Up to 87 months

ID	Title	Description
OG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

Secondary

Complete Response (CR) Rate

The CR rate is defined as the percentage of participants with a best overall response of complete response (CR) or complete response with incomplete marrow recovery (CRi). CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/L; Regression of all target nodal masses to ≤1.5 cm in LD; Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC>1.5x10^9/L,platelets≥100x10^9/L,hemoglobin (Hgb)≥110 g/L. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL.

Posted

Number

percentage of participants

Up to 87 months

ID	Title	Description
OG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
OG001	Active Comparator: Arm B: Obinutuzumab + Chlorambucil

Secondary

Minimal Residual Disease (MRD) Negativity Rate

MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.

Posted

Number

percentage of participants

From Cycle 6 until Cycle 15 (cycle length=28 days) up to approximately 81.5 months

ID	Title	Description
OG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
OG001	Active Comparator: Arm B: Obinutuzumab + Chlorambucil	Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

Secondary

Duration of Response (DOR)

DOR is defined as the interval from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of definitive disease progression or death from any cause.

The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Overall Number of Participants Analyzed is the number of participants with data available for analysis.

Posted

Median

95% Confidence Interval

months

From first documentation of response to study treatment till disease progression/death (up to approximately 87 months)

ID	Title	Description
OG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
OG001	Active Comparator: Arm B: Obinutuzumab + Chlorambucil	Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

Secondary

Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related.

The safety population included all randomized participants who had received at least one dose of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202

Posted

Count of Participants

Participants

From first dose of study treatment up to end of study (up to approximately 87 months)

ID	Title	Description
OG000	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

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	Experimental: Arm A: Ublituximab + Umbralisib	Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	82	206	118	206	205	206
EG001	Active Comparator: Arm B: Obinutuzumab + Chlorambucil	Participants received Obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 15 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with Chlorambucil 0.5 milligram per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	40	200	47	200	189	200
EG002	Experimental: Arm C: Ublituximab	Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	25	91	33	91	84	91
EG003	Experimental: Arm D: Umbralisib	Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.	29	86	34	86	84	86

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0012 affected200 at risk EG0022 affected91 at risk EG0032 affected86 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0012 affected200 at risk EG0021 affected91 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0013 affected200 at risk EG0020 affected91 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Haemolysis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0012 affected200 at risk EG0021 affected91 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0010 affected200 at risk EG0022 affected91 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0022 affected91 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Adrenal mass	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Exfoliation glaucoma	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Eye inflammation	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Glaucoma	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Anal stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Duodenogastric reflux	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected200 at risk EG0022 affected91 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0013 affected200 at risk EG0020 affected91 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Sudden cardiac death	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Adverse drug reaction	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Mucosal inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Sudden death	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Chronic hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0012 affected200 at risk EG0020 affected91 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00021 affected206 at risk EG0014 affected200 at risk EG0024 affected91 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0010 affected200 at risk EG0024 affected91 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00010 affected206 at risk EG0010 affected200 at risk EG0028 affected91 at risk EG003
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 affected206 at risk EG0011 affected200 at risk EG0024 affected91 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 affected206 at risk EG0011 affected200 at risk EG0021 affected91 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected206 at risk EG0013 affected200 at risk EG0020 affected91 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Abscess limb	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Bordetella infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Candida infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Dientamoeba infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Enterovirus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Medical device site joint infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Orchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Parotitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Peritonitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Scrotal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Erysipelas	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Genitourinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Liver abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0021 affected91 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected200 at risk EG0022 affected91 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Liver function test abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Transaminases increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Clostridium test positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
International normalised ratio increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0013 affected200 at risk EG0021 affected91 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected200 at risk EG0021 affected91 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Facial paresis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Intracranial mass	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Transient aphasia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Agitation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Binge drinking	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0022 affected91 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0022 affected91 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0022 affected91 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Vascular compression	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00070 affected206 at risk EG00179 affected200 at risk EG00225 affected91 at risk EG00315 affected86 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00029 affected206 at risk EG00125 affected200 at risk EG00215 affected91 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00021 affected206 at risk EG00144 affected200 at risk EG00213 affected91 at risk EG003
Vision blurred	Eye disorders	MedDRA 23.0	Systematic Assessment	EG00014 affected206 at risk EG0016 affected200 at risk EG0024 affected91 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000118 affected206 at risk EG00145 affected200 at risk EG00224 affected91 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000105 affected206 at risk EG00175 affected200 at risk EG00227 affected91 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00038 affected206 at risk EG00123 affected200 at risk EG00214 affected91 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00038 affected206 at risk EG00129 affected200 at risk EG0029 affected91 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00027 affected206 at risk EG00119 affected200 at risk EG0029 affected91 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00024 affected206 at risk EG0019 affected200 at risk EG0023 affected91 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00015 affected206 at risk EG0015 affected200 at risk EG0021 affected91 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0012 affected200 at risk EG0025 affected91 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected206 at risk EG0015 affected200 at risk EG0026 affected91 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected206 at risk EG0012 affected200 at risk EG0020 affected91 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG00076 affected206 at risk EG00160 affected200 at risk EG00228 affected91 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00053 affected206 at risk EG00138 affected200 at risk EG00222 affected91 at risk EG003
Chills	General disorders	MedDRA 23.0	Systematic Assessment	EG00052 affected206 at risk EG00133 affected200 at risk EG00225 affected91 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG00039 affected206 at risk EG00112 affected200 at risk EG00210 affected91 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG00025 affected206 at risk EG00113 affected200 at risk EG0024 affected91 at risk EG003
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0014 affected200 at risk EG0023 affected91 at risk EG003
Chest discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected206 at risk EG0017 affected200 at risk EG0023 affected91 at risk EG003
Influenza like illness	General disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected206 at risk EG0019 affected200 at risk EG0022 affected91 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG00019 affected206 at risk EG0015 affected200 at risk EG0022 affected91 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00048 affected206 at risk EG00126 affected200 at risk EG00216 affected91 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00027 affected206 at risk EG00111 affected200 at risk EG00210 affected91 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00026 affected206 at risk EG0014 affected200 at risk EG00210 affected91 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00025 affected206 at risk EG0017 affected200 at risk EG0026 affected91 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00020 affected206 at risk EG0015 affected200 at risk EG0025 affected91 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00017 affected206 at risk EG0010 affected200 at risk EG0026 affected91 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00092 affected206 at risk EG00149 affected200 at risk EG00236 affected91 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00018 affected206 at risk EG0019 affected200 at risk EG0027 affected91 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0014 affected200 at risk EG0026 affected91 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00034 affected206 at risk EG0019 affected200 at risk EG0026 affected91 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00029 affected206 at risk EG0019 affected200 at risk EG0026 affected91 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00028 affected206 at risk EG00121 affected200 at risk EG0026 affected91 at risk EG003
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00021 affected206 at risk EG00119 affected200 at risk EG00210 affected91 at risk EG003
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00016 affected206 at risk EG0014 affected200 at risk EG0024 affected91 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00014 affected206 at risk EG00110 affected200 at risk EG0026 affected91 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00042 affected206 at risk EG00118 affected200 at risk EG0026 affected91 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00029 affected206 at risk EG0014 affected200 at risk EG0022 affected91 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00015 affected206 at risk EG0016 affected200 at risk EG0023 affected91 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0015 affected200 at risk EG0025 affected91 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0011 affected200 at risk EG0024 affected91 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected206 at risk EG0017 affected200 at risk EG0023 affected91 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00032 affected206 at risk EG00116 affected200 at risk EG00216 affected91 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00032 affected206 at risk EG00115 affected200 at risk EG00212 affected91 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00020 affected206 at risk EG00111 affected200 at risk EG0024 affected91 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00020 affected206 at risk EG00115 affected200 at risk EG00210 affected91 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected206 at risk EG0017 affected200 at risk EG0028 affected91 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected206 at risk EG0013 affected200 at risk EG0021 affected91 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00056 affected206 at risk EG00136 affected200 at risk EG00218 affected91 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00046 affected206 at risk EG00119 affected200 at risk EG00214 affected91 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00026 affected206 at risk EG0013 affected200 at risk EG0021 affected91 at risk EG003
Tremor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG0013 affected200 at risk EG0025 affected91 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00041 affected206 at risk EG00128 affected200 at risk EG00212 affected91 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00024 affected206 at risk EG00111 affected200 at risk EG0024 affected91 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected206 at risk EG0016 affected200 at risk EG0024 affected91 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00014 affected206 at risk EG0015 affected200 at risk EG0021 affected91 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00062 affected206 at risk EG00136 affected200 at risk EG00218 affected91 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00041 affected206 at risk EG00134 affected200 at risk EG00220 affected91 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00014 affected206 at risk EG0013 affected200 at risk EG0025 affected91 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00017 affected206 at risk EG0013 affected200 at risk EG0028 affected91 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected206 at risk EG0016 affected200 at risk EG0029 affected91 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected206 at risk EG0016 affected200 at risk EG0023 affected91 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00027 affected206 at risk EG0018 affected200 at risk EG0029 affected91 at risk EG003
Flushing	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00016 affected206 at risk EG00118 affected200 at risk EG0029 affected91 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected206 at risk EG00117 affected200 at risk EG00212 affected91 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected206 at risk EG0013 affected200 at risk EG0025 affected91 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected206 at risk EG0013 affected200 at risk EG0020 affected91 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 affected206 at risk EG0010 affected200 at risk EG0021 affected91 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 affected206 at risk EG0010 affected200 at risk EG0020 affected91 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected206 at risk EG0016 affected200 at risk EG0026 affected91 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0012 affected200 at risk EG0026 affected91 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected206 at risk EG0011 affected200 at risk EG0020 affected91 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected200 at risk EG0027 affected91 at risk EG003
White blood cell count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00010 affected206 at risk EG00117 affected200 at risk EG0028 affected91 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 affected206 at risk EG0010 affected200 at risk EG0025 affected91 at risk EG003
Lymphocyte count increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 affected206 at risk EG0012 affected200 at risk EG0020 affected91 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00010 affected206 at risk EG0015 affected200 at risk EG0025 affected91 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0008 affected206 at risk EG0016 affected200 at risk EG0025 affected91 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected206 at risk EG0013 affected200 at risk EG0025 affected91 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected206 at risk EG0015 affected200 at risk EG0021 affected91 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00010 affected206 at risk EG0012 affected200 at risk EG0027 affected91 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 affected206 at risk EG00110 affected200 at risk EG0022 affected91 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected206 at risk EG0013 affected200 at risk EG0026 affected91 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected206 at risk EG0012 affected200 at risk EG0021 affected91 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00010 affected206 at risk EG0015 affected200 at risk EG0021 affected91 at risk EG003
Hot flush	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected206 at risk EG00110 affected200 at risk EG0024 affected91 at risk EG003

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

ID	Term
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Term
C543332	obinutuzumab
C000619007	ublituximab
C000626319	umbralisib
D002699	Chlorambucil