A Phase 2 Safety and Efficacy Study of INCB050465 in Subj... | NCT02998476

ID	Type	Description	Link
Parsaclisib	Other Identifier	Incyte Corporation
2016-002205-19	EudraCT Number

Label	Type	Description	Intervention Names
Group A Parsaclisib (no prior BTK inhibitor)	Experimental	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.	Drug: Parsaclisib
Group B Parsaclisib (prior BTK inhibitor)	Experimental	Parsaclisib in subjects who were previously treated with a BTK inhibitor.	Drug: Parsaclisib

Name	Type	Description	Arm Group Labels	Other Names
Parsaclisib	Drug	Parsaclisib once daily for 8 weeks followed by once weekly	Group A Parsaclisib (no prior BTK inhibitor) Group B Parsaclisib (prior BTK inhibitor)

Measure	Description	Time Frame
Objective Response Rate Based on Lugano Classification Criteria in Group A	Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.	Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

Measure	Description	Time Frame
Duration of Response in Group A	Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.	Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible 19 years and older in South Korea
Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

Primary mediastinal (thymic) large B-cell lymphoma.
Known brain or central nervous system metastases or history of uncontrolled seizures.
Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
Prior treatment with the following:
- Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
- Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

Name	Affiliation	Role
Claudia Corrado, MD	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Banner MD Anderson Cancer Center

PubMed Identifier	Type	Citation	Retractions
33140664	Derived	Coleman M, Belada D, Casasnovas RO, Gressin R, Lee HP, Mehta A, Munoz J, Verhoef G, Corrado C, DeMarini DJ, Zhao W, Li J, Fay K. Phase 2 study of parsaclisib (INCB050465), a highly selective, next-generation PI3Kdelta inhibitor, in relapsed or refractory diffuse large B-cell lymphoma (CITADEL-202). Leuk Lymphoma. 2021 Feb;62(2):368-376. doi: 10.1080/10428194.2020.1832660. Epub 2020 Nov 3.

ID	Title	Description
FG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
FG001	Group B Parsaclisib (Prior BTK Inhibitor)	Parsaclisib in subjects who were previously treated with a BTK inhibitor.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 5, 2019	Feb 21, 2020

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

Objective Response Rate Based on Lugano Classification Criteria in Group A

Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.

The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465

Posted

Number

95% Confidence Interval

percentage

Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

ID	Title	Description
OG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Units	Counts
Participants	OG00055

Title

Denominators

Categories

Title	Measurements
	OG00025.5(14.7 to 39.0)

Secondary

Duration of Response in Group A

Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.

The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465

Posted

Median

95% Confidence Interval

months

Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

ID	Title	Description
OG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Units	Counts
Participants	OG000

Secondary

Progression-free Survival in Group A

Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.

The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465

Posted

Median

95% Confidence Interval

months

Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

ID	Title	Description
OG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) in Group A

Defined as the time from the date of the first dose of study drug until death by any cause.

The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465

Posted

Median

95% Confidence Interval

months

From first dose of study drug until death by any cause; up to 26 months

ID	Title	Description
OG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Units	Counts
Participants	OG00055

Secondary

Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B

A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.

Posted

Count of Participants

Participants

Screening through 35 days after end of treatment, up to 42 months

ID	Title	Description
OG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
OG001	Group B Parsaclisib (Prior BTK Inhibitor)	Parsaclisib in subjects who were previously treated with a BTK inhibitor.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected5 at risk EG0022 events2 affected60 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Confusional state	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected5 at risk EG0022 events2 affected60 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected5 at risk EG0024 events4 affected60 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0003 events1 affected55 at risk EG0010 events0 affected5 at risk EG0023 events1 affected60 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Pericarditis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Presyncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0008 events5 affected55 at risk EG0010 events0 affected5 at risk EG0028 events5 affected60 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected5 at risk EG0022 events2 affected60 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Septic shock	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Staphylococcal infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected5 at risk EG0022 events2 affected60 at risk
Urosepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected5 at risk EG0022 events2 affected60 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected5 at risk EG0021 events1 affected60 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0006 events4 affected55 at risk EG0010 events0 affected5 at risk EG0026 events4 affected60 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected5 at risk EG0024 events4 affected60 at risk
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0011 events1 affected5 at risk EG0024 events4 affected60 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0011 events1 affected5 at risk EG0024 events4 affected60 at risk
Balance disorder	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Chills	General disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected55 at risk EG0010 events0 affected5 at risk EG0025 events5 affected60 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00010 events9 affected55 at risk EG0010 events0 affected5 at risk EG00210 events9 affected60 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected55 at risk EG0010 events0 affected5 at risk EG0025 events5 affected60 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00011 events10 affected55 at risk EG0010 events0 affected5 at risk EG00211 events10 affected60 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0007 events7 affected55 at risk EG0012 events1 affected5 at risk EG0029 events8 affected60 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected5 at risk EG0022 events2 affected60 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected5 at risk EG0024 events4 affected60 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected55 at risk EG0011 events1 affected5 at risk EG0025 events5 affected60 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected5 at risk EG0022 events2 affected60 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected55 at risk EG0010 events0 affected5 at risk EG0024 events3 affected60 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected55 at risk EG0010 events0 affected5 at risk EG0024 events3 affected60 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0006 events3 affected55 at risk EG0010 events0 affected5 at risk EG0026 events3 affected60 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0011 events1 affected5 at risk EG0024 events4 affected60 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected5 at risk EG0022 events2 affected60 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events1 affected55 at risk EG0011 events1 affected5 at risk EG0024 events2 affected60 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00011 events11 affected55 at risk EG0010 events0 affected5 at risk EG00211 events11 affected60 at risk
Neutrophil count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected55 at risk EG0010 events0 affected5 at risk EG0025 events5 affected60 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected5 at risk EG0022 events2 affected60 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected5 at risk EG0024 events4 affected60 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Polyneuropathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected55 at risk EG0011 events1 affected5 at risk EG0025 events4 affected60 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0007 events5 affected55 at risk EG0010 events0 affected5 at risk EG0027 events5 affected60 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected55 at risk EG0011 events1 affected5 at risk EG0023 events3 affected60 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected5 at risk EG0023 events3 affected60 at risk
Rhinitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected5 at risk EG0022 events2 affected60 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected5 at risk EG0021 events1 affected60 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected5 at risk EG0024 events4 affected60 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected5 at risk EG0022 events2 affected60 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0005 events4 affected55 at risk EG0010 events0 affected5 at risk EG0025 events4 affected60 at risk
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected55 at risk EG0011 events1 affected5 at risk EG0024 events4 affected60 at risk

ID	Term
D008223	Lymphoma
D016403	Lymphoma, Large B-Cell, Diffuse
D012008	Recurrence
D008228	Lymphoma, Non-Hodgkin

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016393	Lymphoma, B-Cell
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
BG001	Group B Parsaclisib (Prior BTK Inhibitor)	Parsaclisib in subjects who were previously treated with a BTK inhibitor.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A Parsaclisib (no Prior BTK Inhibitor)	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.	45	55	39	55	41	55
EG001	Group B Parsaclisib (Prior BTK Inhibitor)	Parsaclisib in subjects who were previously treated with a BTK inhibitor.	3	5	2	5	3	5
EG002	Total	Total	48	60	41	60	44	60