Phase 3 Study of Zandelisib (ME-401) in Combination With... | NCT04745832

NCT04745832

ID	Type	Description	Link
2020-004199-16	EudraCT Number

Status Module

Name	Class
Kyowa Kirin, Inc.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rituximab plus Zandelisib	Experimental	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles	Drug: Zandelisib Drug: Rituximab
Rituximab plus chemotherapy	Experimental	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles	Drug: Rituximab Drug: Bendamustine Drug: CHOP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zandelisib	Drug	Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3	Rituximab plus Zandelisib

Outcomes Module

Measure	Description	Time Frame
Progression Free Survival	PFS is defined as the time from randomization date until the date of disease progression, or death from any cause	1 year 7 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period.	1 year 7 months
Complete Response Rate (CRR)

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
The Oncology Institute of Hope and Innovation		Tucson	Arizona	85745	United States
Orange Coast Memorial Medical Center

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 7, 2021	Oct 25, 2023

Arm/Group Information

ID	Title	Description
BG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles
BG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

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

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00024 BG00125 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Hungary

Title	Measurements
	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival

PFS is defined as the time from randomization date until the date of disease progression, or death from any cause

A decision was made to terminate this Phase 3 study early due to business reasons. For the 82 subjects enrolled no scans had been collected at the time of termination, therefore no data were analyzed.

Posted

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP

Units	Counts
Participants	OG0000 OG0010

Secondary

Overall Response Rate (ORR)

ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period.

Posted

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP

Units	Counts

Secondary

Complete Response Rate (CRR)

CRR is defined as the proportion of subjects who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).

A decision was made to terminate this Phase 3 study early due to business reasons. For the 84 subjects enrolled no scans had been collected at the time of termination, therefore no data were analyzed.

Posted

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Units	Counts
Participants

Secondary

Overall Survival

OS is defined as the time (in days) from randomization until death from any cause. For subjects alive at the time of analysis, they will be censored at the last documented alive date.

A decision was made to terminate this Phase 3 study early due to business reasons, therefore no data were collected or analyzed.

Posted

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP

Units	Counts
Participants

Secondary

Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)

Measured by the number of Treatment Emergent AEs

Of the 41 subjects enrolled to the R+Zandelisib group 38 had a Treatment Emergent AE Of the 41 subjects enrolled to the R-Chemo group 37 had a Treatment Emergent AE

Posted

Count of Participants

Participants

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP

Units	Counts
Participants

Secondary

Number of SAEs (Zandelisib When Combined With Rituximab)

Measured by the number of SAEs

Posted

Count of Participants

Participants

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP

Units	Counts
Participants	OG000

Secondary

Number of Lab Abnormalities (Zandelisib When Combined With Rituximab)

Measured by the number of laboratory abnormalities

A decision was made to terminate this Phase 3 study early due to business reasons. For the 82 subjects enrolled no lab abnormalities had been collected or analyzed

Posted

1 year 7 months

ID	Title	Description
OG000	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled
OG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP

Units	Counts
Participants

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	Rituximab Plus Zandelisib	Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles In the Rituximab plus Zandelisib arm, 41 subjects enrolled	1	41	12	41	38	41
EG001	Rituximab Plus Chemotherapy	Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP	1	41	8	41	37	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0012 events2 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0011 events1 affected41 at risk
Pyrexia	General disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
COVID-19	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0002 events2 affected41 at risk EG0010 events0 affected41 at risk
Device related infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0004 events4 affected41 at risk EG0010 events0 affected41 at risk
Pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Vascular device infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Cytomegalovirus test positive	Investigations	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Suspected Infection of unknown origin	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 events1 affected41 at risk EG0011 events1 affected41 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0014 affected41 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0012 affected41 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0012 affected41 at risk
Palpitations	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Goitre	Endocrine disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Corneal disorder	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Vision blurred	Eye disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0003 affected41 at risk EG0012 affected41 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0003 affected41 at risk EG0012 affected41 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Constipation	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0006 affected41 at risk EG0016 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG00015 affected41 at risk EG0012 affected41 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0010 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0004 affected41 at risk EG00113 affected41 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0005 affected41 at risk EG0012 affected41 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0016 affected41 at risk
Asthenia	General disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0012 affected41 at risk
Chills	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Fatigue	General disorders	MedDRA 24	Systematic Assessment	EG0003 affected41 at risk EG0012 affected41 at risk
Generalised oedema	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Injection site phlebitis	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Injection site reaction	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Malaise	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0012 affected41 at risk
Mucosal inflammation	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Non-cardiac chest pain	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Oedema peripheral	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0012 affected41 at risk
Pain	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Peripheral swelling	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Pyrexia	General disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0017 affected41 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Bronchitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0010 affected41 at risk
COVID-19	Infections and infestations	MedDRA 24	Systematic Assessment	EG00011 affected41 at risk EG0016 affected41 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0010 affected41 at risk
Candida infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Conjunctivitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Cystitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0003 affected41 at risk EG0011 affected41 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Device related infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Ear infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Gastrointestinal fungal infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Herpes simplex	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Herpes zoster	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Hordeolum	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Infected cyst	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Nail infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Pharyngitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0004 affected41 at risk EG0010 affected41 at risk
Pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0013 affected41 at risk
Urinary tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Vascular device infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Chillblains	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0006 affected41 at risk EG0011 affected41 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Beta 2 microglobulin increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Blood creatinine increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Blood uric acid increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
C-reactive protein increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Cytomegalovirus test positive	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Ejection fraction decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Electrocardiogram QRS complex prolonged	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Lymphocyte count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0013 affected41 at risk
Lymphocyte count increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Neutrophil count decreased	Investigations	MedDRA 24	Systematic Assessment	EG00010 affected41 at risk EG0017 affected41 at risk
Platelet count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Weight decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
White blood cell count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0012 affected41 at risk
White blood cell count increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0016 affected41 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0003 affected41 at risk EG0012 affected41 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0012 affected41 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0012 affected41 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Dizziness	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Dysgeusia	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0012 affected41 at risk
Headache	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0003 affected41 at risk EG0013 affected41 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0013 affected41 at risk
Presyncope	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Insomnia	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Nocturia	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Renal failure	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0004 affected41 at risk EG0013 affected41 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0004 affected41 at risk EG0011 affected41 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Pharyngeal swelling	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0012 affected41 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0011 affected41 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0011 affected41 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0010 affected41 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0011 affected41 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected41 at risk EG0013 affected41 at risk
Hypertension	Vascular disorders	MedDRA 24	Systematic Assessment	EG0002 affected41 at risk EG0010 affected41 at risk
Suspected Infection of unknown origin	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0016 affected41 at risk
AST ALT increase	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected41 at risk EG0016 affected41 at risk

Ancestor Terms

ID	Term
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
D002264	Carboxylic Acids
D009930	Organic Chemicals
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D010752	Phosphoramide Mustards
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Term
D008224	Lymphoma, Follicular
D008228	Lymphoma, Non-Hodgkin
D018442	Lymphoma, B-Cell, Marginal Zone

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016393	Lymphoma, B-Cell

ID	Term
C000654193	ME-401
D000069283	Rituximab
D000069461	Bendamustine Hydrochloride
D003520	Cyclophosphamide
D011241	Prednisone