A Study to Determine Dose, Safety, and Efficacy of Durval... | NCT02733042

NCT02733042

ID	Type	Description	Link
2015-003516-21	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Durvalumab + Lenalidomide ± Rituximab	Experimental	Participants assigned to Arm A will receive: Durvalumab 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and Lenalidomide orally at assigned dose levels (10 mg, 15 mg or 20 mg) once daily on Days 1 to 21 of: Cycles 1 through 13 in indolent non-Hodgkin's lymphoma (NHL) or All cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL Rituximab 375 mg/m² IV infusion every week in Cycle 1 (Days 2, 8, 15, 22) and on Day 1 of Cycles 2 through 5. All treatment cycles were 28 days.	Drug: Durvalumab Drug: Lenalidomide Drug: Rituximab
Arm B: Durvalumab + Ibrutinib	Experimental	Participants assigned to Arm B will receive: Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 Ibrutinib orally at assigned dose levels (280 mg, 420 mg, or 560 mg) once daily until disease progression, unacceptable toxicity or discontinuation for any other reason. All treatment cycles were 28 days.	Drug: Durvalumab Drug: Ibrutinib
Arm C: Durvalumab + Rituximab ± Bendamustine	Experimental	Participants assigned to Arm C will receive: Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 Rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose will be 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose) Bendamustine IV infusion at assigned dose levels (70 mg/m² or 90 mg/m²) on Days 1 and 2 of Cycles 1 through 6. All treatment cycles were 28 days.	Drug: Durvalumab Drug: Rituximab Drug: Bendamustine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Durvalumab	Drug	Administered as an IV infusion (250 mL) over approximately 1 hour in duration	Arm A: Durvalumab + Lenalidomide ± Rituximab Arm B: Durvalumab + Ibrutinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below: Hematologic DLT • Grade 4 neutropenia observed for greater than 5 days duration • Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or any requirement for platelets transfusion • Grade 4 anemia, unexplained by underlying disease • Any other grade 4 hematologic toxicity that does not resolve to participant's pretreatment baseline level within 72 hours. Non-Hematologic DLT • Any non-hematological toxicity ≥ Grade 3 except for alopecia and nausea controlled by medical management • Any treatment interruption greater than 2 weeks due to adverse event.	Cycle 1 (28 days)
Number of Participants With Treatment-emergent Adverse Events	Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) occurring or worsening on or after the first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. The intensity of AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5).	From first dose of any study drug to 90 days after last dose of durvalumab or 28 days after last dose of other study drugs, up to the data cut-off date of 6 March 2019. Maximum time on treatment was 55.4 weeks for DUR and 130 weeks for other study drugs.

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR) During Durvalumab Treatment	For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percent of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who has histologically confirmed and documented B-cell lymphoma (eg, follicular, diffuse large B-cell, mantle cell, small lymphocytic, or Hodgkin lymphoma) and chronic lymphocytic leukemia.
Subject who has high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
Subject who has the Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Subject who is willing and able to undergo biopsy.
Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
Subject with lymphoma who has measurable disease (≥ 2.0 cm in its longest dimension by computed tomography) or chronic lymphocytic leukemia in need of treatment.
Subject who fulfills the laboratory requirements as per protocol

Exclusion Criteria

Subject who has central nervous system (CNS) or meningeal involvement by lymphoma.
Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.
Subject who received any prior monoclonal antibodies against programmed cell death-1 (PD-1) or programmed cell death ligand-1 (PD-L1) and/or any prior:
1. Arm A only: drugs with immunomodulatory and other properties (eg, lenalidomide, thalidomide);
2. Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
3. Arms C only: bendamustine
Subject who has active auto-immune disease.
Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
Subject who has known seropositivity for or active infection for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
Subject who has history of primary immunodeficiency or tuberculosis.
Subject who other invasive malignancy within 2 years (5 years for Arm A) except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured.

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center		Gilbert	Arizona	85234	United States
Pinnacle Oncology Hematology

PubMed Identifier	Type	Citation	Retractions
35852004	Derived	Casulo C, Santoro A, Cartron G, Ando K, Munoz J, Le Gouill S, Izutsu K, Rule S, Lugtenburg P, Ruan J, Arcaini L, Casadebaig ML, Fox B, Kilavuz N, Rettby N, Dell'Aringa J, Taningco L, Delarue R, Czuczman M, Witzig T. Durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia: The FUSION NHL 001 trial. Cancer Rep (Hoboken). 2023 Jan;6(1):e1662. doi: 10.1002/cnr2.1662. Epub 2022 Jul 19.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.

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 22, 2020	Nov 15, 2023

Arm/Group Information

ID	Title	Description
BG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
BG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
BG002	Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
BG003	Part 1, Arm B: DUR 1500 mg + IBR 420 mg	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib (IBR) 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
BG004	Part 1, Arm B: DUR 1500 mg + IBR 560 mg	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
BG005	Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
BG006	Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine (BEN) 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.
BG007	Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
BG008	Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 90 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
BG009	Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mg	Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
BG010	Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg	Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
BG011	Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
BG012	Part 2 Arm C DLBCL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
BG013	Part 2, Arm C CLL/SLL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
BG014	Part 2, Arm D FL: DUR 1500 mg	Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
BG015	Part 2, Arm D DLBCL: DUR 1500 mg	Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
BG016	Part 2, Arm D CLL/SLL: DUR 1500 mg	Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
BG017	Part 2, Arm D MCL: DUR 1500 mg	Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
BG018	Part 2, Arm D HL: DUR 1500 mg	Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
BG019	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

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00071.0(50 to 78) BG00166.0(52 to 75) BG00277.0(53 to 80) BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65 Years	BG0001 BG0011 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG0002 BG0012 BG002

Histology

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Follicular lymphoma	BG0001 BG0013 BG002

Eastern Cooperative Oncology Group ECOG) Performance Status

ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: • 0 = Fully active, no restrictions; • 1 = Restricted activity but ambulatory, able to carry out work of a light nature; • 2 = Ambulatory and capable of all self-care but unable to carry out work activities; • 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; • 4 = Completely disabled, no selfcare, confined to bed or chair; • 5 = Dead

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0 - Fully Active	BG0000 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below: Hematologic DLT • Grade 4 neutropenia observed for greater than 5 days duration • Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or any requirement for platelets transfusion • Grade 4 anemia, unexplained by underlying disease • Any other grade 4 hematologic toxicity that does not resolve to participant's pretreatment baseline level within 72 hours. Non-Hematologic DLT • Any non-hematological toxicity ≥ Grade 3 except for alopecia and nausea controlled by medical management • Any treatment interruption greater than 2 weeks due to adverse event.

DLT Evaluable population included participants in Arms A, B, and C of Part 1, who took at least one dose of study drug and completed the DLT evaluation through the end of DLT evaluation period, or participants who took at least one dose of study drug and experienced at least one DLT prior to completion of the DLT evaluation period.

Posted

Count of Participants

Participants

Cycle 1 (28 days)

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
OG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
OG002	Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
OG003	Part 1, Arm B: DUR 1500 mg + IBR 420 mg	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib (IBR) 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG004

Units	Counts
Participants	OG0003 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0013 OG0021 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG003 OG004	The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).																	Other		For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.

Primary

Number of Participants With Treatment-emergent Adverse Events

Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) occurring or worsening on or after the first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. The intensity of AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5).

The Safety population included all participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

From first dose of any study drug to 90 days after last dose of durvalumab or 28 days after last dose of other study drugs, up to the data cut-off date of 6 March 2019. Maximum time on treatment was 55.4 weeks for DUR and 130 weeks for other study drugs.

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.

Secondary

Overall Response Rate (ORR) During Durvalumab Treatment

For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percent of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

The Efficacy Evaluable population includes all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 13 cycles (12 months)

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
OG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²

Secondary

Overall Response Rate During the Entire Study

For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification) (Cheson, 2014). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percentage of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

The Efficacy Evaluable population includes all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.

Secondary

Time to First Response

Time to response was calculated as the time from first dose of study drug to the first response date (CR or PR for lymphoma participants and CR, CRi, nPR, PR, or PRL for CLL participants).

Efficacy evaluable population (all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment) who had an objective response

Posted

Median

Full Range

weeks

From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
OG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.

Secondary

Kaplan-Meier Estimate of Duration of Response

Duration of response is defined for responders only as the time from the first documented response (CR or PR for lymphoma participants or CR, CRi, nPR, PR, or PRL for CLL participants) to disease progression or death (from any cause). For participants with response but no progression, or death, duration of response was censored at the last date that the participant was known to be progression-free.

Posted

Median

95% Confidence Interval

weeks

From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
OG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.

Secondary

Kaplan-Meier Estimate of Progression-free Survival (PFS)

Progression-free survival was calculated as the time from first dose of study drug to the first documented progression or death (from any cause) during the entire efficacy evaluation period. For participants with no progression or death, PFS was censored at the last assessment date the participant was known to be progression-free.

Safety population

Posted

Median

95% Confidence Interval

months

From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
OG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.

Secondary

Maximum Observed Plasma Concentration (Cmax) of Durvalumab

The Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/L

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide ± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Time to Maximum Plasma Concentration (Tmax) of Durvalumab

PK population

Posted

Median

Full Range

days

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide ± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Durvalumab

The PK population

Posted

Geometric Mean

Geometric Coefficient of Variation

days*μg/L

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide ± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Durvalumab

The PK population

Posted

Geometric Mean

Geometric Coefficient of Variation

days*μg/L

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide ± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Terminal Elimination Phase Half-Life (t½) of Durvalumab

The PK population

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

days

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide Â± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Clearance (CL) of Durvalumab

The PK population

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

L/day

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide ± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Volume of Distribution (Vz) of Durvalumab

The PK population

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

liters

Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

ID	Title	Description
OG000	Arm A: Durvalumab + Lenalidomide ± Rituximab	Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm B: Durvalumab + Ibrutinib	Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
OG002	Arm C: Durvalumab + Bendamustine ± Rituximab	Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Secondary

Maximum Observed Plasma Concentration (Cmax) of Lenalidomide

PK population with available data at each time point

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

ID	Title	Description
OG000	Arm A: Lenalidomide 10 mg	Participants in Arm A received lenalidomide 10 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm A: Lenalidomide 20 mg	Participants in Arm A received lenalidomide 20 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.

Units	Counts

Secondary

Time to Maximum Observed Plasma Concentration (Tmax) of Lenalidomide

PK population with available data at each time point

Posted

Median

Full Range

hours

Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

ID	Title	Description
OG000	Arm A: Lenalidomide 10 mg	Participants in Arm A received lenalidomide 10 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm A: Lenalidomide 20 mg	Participants in Arm A received lenalidomide 20 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.

Units	Counts

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Lenalidomide

PK population with available data

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

h*ng/mL

Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose

ID	Title	Description
OG000	Arm A: Lenalidomide 10 mg	Participants in Arm A received lenalidomide 10 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
OG001	Arm A: Lenalidomide 20 mg	Participants in Arm A received lenalidomide 20 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.

Units	Counts

Secondary

Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

PK population with available data at each time point

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

ID	Title	Description
OG000	Arm B: Ibrutinib 420 mg	Participants assigned to Arm B received 420 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.
OG001	Arm B: Ibrutinib 560 mg	Participants assigned to Arm B received 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.

Units	Counts
Participants	OG000

Secondary

Time to Maximum Observed Plasma Concentration (Tmax) of Ibrutinib

PK population with available data at each time point

Posted

Median

Full Range

hours

Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

ID	Title	Description
OG000	Arm B: Ibrutinib 420 mg	Participants assigned to Arm B received 420 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.
OG001	Arm B: Ibrutinib 560 mg	Participants assigned to Arm B received 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Ibrutinib

PK population with available data

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

h*ng/mL

Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose

ID	Title	Description
OG000	Arm B: Ibrutinib 420 mg	Participants assigned to Arm B received 420 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.
OG001	Arm B: Ibrutinib 560 mg	Participants assigned to Arm B received 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Soluble Programmed Cell Death Ligand-1 (sPD-L1) Concentration

Change from baseline in sPD-L1 could not be calculated as all post-baseline samples were below the lower limit of quantification (<15.60 pg/mL).

Biomarker Evaluable Population included all participants who received at least 1 dose of study drug and had at least 1 non-missing biomarker assessment. No participants had quantifiable sPD-L1 measurements post-baseline.

Posted

Baseline (Cycle 1 Day 1 predose) and Day 1 of Cycles 2 to 13

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
OG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.

Post-Hoc

Number of Participants With Treatment-emergent Adverse Events (TEAEs) - Extended Collection

TEAEs defined as AEs occurring or worsening on or after first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. Intensity of AEs graded according to the NCI CTCAE V. 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5). This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date (assessments made until August 21, 2022).

The Safety population included all participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

From first dose of any study drug to 90 days after last dose of durvalumab or 28 days after last dose of other study drugs, up to the study completion date of August 21, 2022 (up to approximately 75 months).

ID	Title	Description
OG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1, Arm A: DUR 1500 mg + LEN 20 mg	Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.	1	3	1	3	3	3
EG001	Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.	1	3	2	3	3	3
EG002	Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²	Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.	2	8	4	8	8	8
EG003	Part 1, Arm B: DUR 1500 mg + IBR 420 mg	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib (IBR) 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.	0	3	2	3	3	3
EG004	Part 1, Arm B: DUR 1500 mg + IBR 560 mg	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.	3	4	3	4	4	4
EG005	Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).	2	3	2	3	3	3
EG006	Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine (BEN) 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.	1	1	1	1	1	1
EG007	Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).	3	4	1	4	4	4
EG008	Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 90 mg/m²	Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).	4	5	3	5	5	5
EG009	Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mg	Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.	1	10	6	10	10	10
EG010	Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg	Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.	2	10	7	10	10	10
EG011	Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.	0	10	5	10	10	10
EG012	Part 2 Arm C DLBCL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.	9	10	5	10	9	10
EG013	Part 2, Arm C CLL/SLL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²	Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).	2	5	2	5	5	5
EG014	Part 2, Arm D FL: DUR 1500 mg	Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.	4	5	4	5	5	5
EG015	Part 2, Arm D DLBCL: DUR 1500 mg	Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.	9	10	8	10	10	10
EG016	Part 2, Arm D CLL/SLL: DUR 1500 mg	Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.	0	2	0	2	2	2
EG017	Part 2, Arm D MCL: DUR 1500 mg	Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.	4	5	4	5	5	5
EG018	Part 2, Arm D HL: DUR 1500 mg	Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.	4	5	2	5	5	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG0030 affected3 at risk EG0041 affected4 at risk EG0050 affected3 at risk EG0060 affected1 at risk EG0070 affected4 at risk EG0081 affected5 at risk EG0090 affected10 at risk EG0100 affected10 at risk EG0110 affected10 at risk EG0120 affected10 at risk EG0130 affected5 at risk EG0140 affected5 at risk EG0150 affected10 at risk EG0160 affected2 at risk EG0170 affected5 at risk EG0180 affected5 at risk
Cytopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Neutropenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Acute coronary syndrome	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Atrial fibrillation	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cardiac failure	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Myocardial infarction	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Adrenal insufficiency	Endocrine disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Aptyalism	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Colon dysplasia	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Haematemesis	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Asthenia	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
General physical health deterioration	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Generalised oedema	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Malaise	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Multiple organ dysfunction syndrome	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pain	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Hepatitis	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cytokine release syndrome	Immune system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bronchiolitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bronchitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Bronchitis viral	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cellulitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Influenza	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lower respiratory tract infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lower respiratory tract infection viral	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lung infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Neutropenic sepsis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Parainfluenzae virus infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pleural infection bacterial	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonia	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sepsis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Septic shock	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sinusitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Streptococcal infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vascular device infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Electrocardiogram QT prolonged	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
General physical condition abnormal	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cerebral ischaemia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Syncope	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Acute kidney injury	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypotension	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Jugular vein thrombosis	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Superior vena cava syndrome	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0023 affected8 at risk EG0030 affected3 at risk EG0042 affected4 at risk EG0050 affected3 at risk EG0060 affected1 at risk EG0071 affected4 at risk EG0083 affected5 at risk EG0090 affected10 at risk EG0103 affected10 at risk EG0111 affected10 at risk EG0125 affected10 at risk EG0131 affected5 at risk EG0141 affected5 at risk EG0152 affected10 at risk EG0162 affected2 at risk EG0171 affected5 at risk EG0182 affected5 at risk
Eosinophilia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Leukopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected8 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Neutropenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0024 affected8 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Atrial fibrillation	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Palpitations	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pericardial disease	Cardiac disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sinus tachycardia	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tachycardia	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Epidermolysis	Congenital, familial and genetic disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Ear discomfort	Ear and labyrinth disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Ear pain	Ear and labyrinth disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypoacusis	Ear and labyrinth disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tinnitus	Ear and labyrinth disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vertigo	Ear and labyrinth disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperthyroidism	Endocrine disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Hypothyroidism	Endocrine disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Thyroiditis	Endocrine disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Blepharitis	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Cataract	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Conjunctival haemorrhage	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dry eye	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Retinopathy hypertensive	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal distension	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Constipation	Gastrointestinal disorders	22.0	Systematic Assessment	EG0003 affected3 at risk EG0011 affected3 at risk EG0024 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Dry mouth	Gastrointestinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dyspepsia	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dysphagia	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Flatulence	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gingival pain	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Haemorrhoids	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Mouth ulceration	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Nausea	Gastrointestinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Oral pain	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Stomatitis	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Asthenia	General disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Chills	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Early satiety	General disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Fatigue	General disorders	22.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0022 affected8 at risk EG003
General physical health deterioration	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Influenza like illness	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Malaise	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Mucosal inflammation	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Non-cardiac chest pain	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Oedema peripheral	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Pain	General disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Hepatitis	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hepatocellular injury	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Drug hypersensitivity	Immune system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Immunodeficiency	Immune system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bronchiolitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bronchitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Cystitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Cytomegalovirus infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Folliculitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Gastroenteritis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastroenteritis viral	Infections and infestations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Herpes zoster	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Influenza	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Laryngitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lip infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Lower respiratory tract infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Lung infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Metapneumovirus infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Nasopharyngitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Oral candidiasis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Oral fungal infection	Infections and infestations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Otitis externa	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Paronychia	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonia	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Respiratory tract infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rhinitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rhinovirus infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Sinusitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tonsillitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tooth infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary tract infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Viral infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Contusion	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Fall	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Overdose	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Wound	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Blood alkaline phosphatase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Blood bilirubin increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood creatine phosphokinase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Blood creatinine increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Blood glucose increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Gamma-glutamyltransferase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Immunoglobulins decreased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lipase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Lymphocyte count decreased	Investigations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Platelet count decreased	Investigations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Weight decreased	Investigations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
White blood cell count decreased	Investigations	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Muscle discomfort	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0002 affected3 at risk EG0013 affected3 at risk EG0020 affected8 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Aphasia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dizziness	Nervous system disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dysaesthesia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Dysgeusia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Headache	Nervous system disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0020 affected8 at risk EG003
Migraine	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Paraesthesia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Tremor	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Anxiety	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Apathy	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Confusional state	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Depression	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Insomnia	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Acute kidney injury	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Dysuria	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Haematuria	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Micturition urgency	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Renal failure	Renal and urinary disorders	22.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected8 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sinus disorder	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Haematoma	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypertension	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypotension	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Venous thrombosis limb	Vascular disorders	22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bone marrow failure	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sinus bradycardia	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Supraventricular tachycardia	Cardiac disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Angle closure glaucoma	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Conjunctival oedema	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Conjunctivitis allergic	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eyelid disorder	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eyelid ptosis	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Iritis	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Periorbital oedema	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vision blurred	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Visual impairment	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vitreous detachment	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vitreous floaters	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vitreous haemorrhage	Eye disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal hernia	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Anal fissure	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ascites	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dental caries	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eructation	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastritis	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Haematemesis	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lip dry	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lip haematoma	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oesophageal pain	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Proctalgia	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Toothache	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Discomfort	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Face oedema	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Feeling hot	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gait disturbance	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gravitational oedema	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Inflammation	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Injection site bruising	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Localised oedema	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Nodule	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Peripheral swelling	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumatosis	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Temperature intolerance	General disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cholestasis	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ocular icterus	Hepatobiliary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Seasonal allergy	Immune system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bacterial sepsis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Chronic sinusitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Conjunctivitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ear infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Enterocolitis infectious	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eye infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Herpes ophthalmic	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Herpes simplex	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Herpes virus infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hordeolum	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Human herpesvirus 6 infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Otitis media	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Otitis media acute	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pharyngitis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonia pseudomonal	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Prostate infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pseudomonas infection	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sepsis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Stenotrophomonas sepsis	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary tract infection viral	Infections and infestations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Allergic transfusion reaction	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Joint injury	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Limb injury	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Neck injury	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Amylase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood calcium decreased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood lactate dehydrogenase increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood uric acid increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood urine present	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Creatinine renal clearance increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Heart rate irregular	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
International normalised ratio increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lymphocyte count increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Monocyte count increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Neutrophil count decreased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Streptococcus test positive	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urine output decreased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Weight increased	Investigations	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gout	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperlactacidaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Polydipsia	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Joint noise	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Limb mass	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Muscle mass	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Amnesia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Depressed level of consciousness	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypoaesthesia	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lethargy	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Memory impairment	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sciatica	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sensory disturbance	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Somnolence	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Syncope	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Taste disorder	Nervous system disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cardiovascular somatic symptom disorder	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Disorientation	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Irritability	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Panic attack	Psychiatric disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pollakiuria	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Renal colic	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Renal impairment	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ureterolithiasis	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary incontinence	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary tract pain	Renal and urinary disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pelvic pain	Reproductive system and breast disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Penile oedema	Reproductive system and breast disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Allergic cough	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Eczema nummular	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Neurodermatitis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Aortic stenosis	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Axillary vein thrombosis	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Deep vein thrombosis	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Embolism	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Embolism venous	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Shock	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Subclavian vein thrombosis	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Venous thrombosis	Vascular disorders	22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D002087	Butyrates
D000144	Acids, Acyclic
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles

ID	Term
D008223	Lymphoma
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008206	Lymphatic Diseases
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease
D008224	Lymphoma, Follicular
D016403	Lymphoma, Large B-Cell, Diffuse
D020522	Lymphoma, Mantle-Cell
D007154	Immune System Diseases
D007160	Immunoproliferative Disorders
D008232	Lymphoproliferative Disorders

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

ID	Term
C000613593	durvalumab
D000077269	Lenalidomide
D000069283	Rituximab
C551803	ibrutinib
D000069461	Bendamustine Hydrochloride