Trial Outcomes & Findings for Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) (NCT NCT04745832)

NCT ID: NCT04745832

Last Updated: 2024-11-04

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: 1 year 7 months
• Results posted on: 2024-11-04

Participant Flow

This study was open from August 2021 through March 2023 at 144 investigational sites in the US, Argentina, Australia, Belgium, Canada, Czech Republic France Georgia, Germany, Greece, Hungary, Ireland, Italy, Japan, Korea, Netherlands, Poland, Serbia, Spain, Taiwan, Turkey, and UK Originally, it was anticipated that approximately 534 subjects would be randomized into the study however the study was terminated for business reasons with 82 subjects enrolled and dosed.

Participant milestones

Measure	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	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
Overall Study STARTED	41	41
Overall Study COMPLETED	41	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Baseline characteristics by cohort

Measure	Rituximab Plus Zandelisib n=41 Participants 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	Rituximab Plus Chemotherapy n=41 Participants 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	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	25 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	16 Participants n=93 Participants	18 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	21 Participants n=93 Participants	19 Participants n=4 Participants	40 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment Hungary	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment United States	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment Japan	10 participants n=93 Participants	7 participants n=4 Participants	17 participants n=27 Participants
Region of Enrollment United Kingdom	4 participants n=93 Participants	2 participants n=4 Participants	6 participants n=27 Participants
Region of Enrollment Spain	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment New Zealand	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment Netherlands	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment South Korea	5 participants n=93 Participants	10 participants n=4 Participants	15 participants n=27 Participants
Region of Enrollment Turkey	1 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment Belgium	3 participants n=93 Participants	1 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment Taiwan	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Region of Enrollment Poland	1 participants n=93 Participants	4 participants n=4 Participants	5 participants n=27 Participants
Region of Enrollment Italy	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants
Region of Enrollment Georgia	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Region of Enrollment France	3 participants n=93 Participants	3 participants n=4 Participants	6 participants n=27 Participants
Region of Enrollment Serbia	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 year 7 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year 7 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year 7 months

Population: 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.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year 7 months

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year 7 months

Population: 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

Measured by the number of Treatment Emergent AEs

Outcome measures

Measure	Rituximab Plus Zandelisib n=41 Participants 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	Rituximab Plus Chemotherapy n=41 Participants 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
Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)	38 Participants	37 Participants

SECONDARY outcome

Timeframe: 1 year 7 months

Measured by the number of SAEs

Outcome measures

Measure	Rituximab Plus Zandelisib n=41 Participants 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	Rituximab Plus Chemotherapy n=41 Participants 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
Number of SAEs (Zandelisib When Combined With Rituximab)	12 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 year 7 months

Population: 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

Measured by the number of laboratory abnormalities

Outcome measures

Outcome data not reported

Adverse Events

Rituximab Plus Zandelisib

Serious events: 12 serious events

Other events: 38 other events

Deaths: 1 deaths

Rituximab Plus Chemotherapy

Serious events: 8 serious events

Other events: 37 other events

Deaths: 1 deaths

Serious adverse events

Measure	Rituximab Plus Zandelisib n=41 participants at risk 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	Rituximab Plus Chemotherapy n=41 participants at risk 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
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • Number of events 2 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Abdominal pain	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Diarrhoea	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Stomatitis	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Vomiting	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Pyrexia	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Hepatobiliary disorders Liver disorder	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations COVID-19	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations COVID-19 pneumonia	4.9% 2/41 • Number of events 2 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Device related infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Pneumocystis jirovecii pneumonia	9.8% 4/41 • Number of events 4 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Pneumonia	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Respiratory tract infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Vascular device infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Cytomegalovirus test positive	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hypokalaemia	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Rash	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Suspected Infection of unknown origin	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • Number of events 1 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.

Other adverse events

Measure	Rituximab Plus Zandelisib n=41 participants at risk 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	Rituximab Plus Chemotherapy n=41 participants at risk 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
Blood and lymphatic system disorders Anaemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	9.8% 4/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Blood and lymphatic system disorders Neutropenia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Cardiac disorders Palpitations	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Cardiac disorders Supraventricular extrasystoles	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Cardiac disorders Supraventricular tachycardia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Ear and labyrinth disorders Hypoacusis	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Ear and labyrinth disorders Vertigo	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Ear and labyrinth disorders Vertigo positional	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Endocrine disorders Goitre	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Endocrine disorders Hyperparathyroidism	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Eye disorders Conjunctival haemorrhage	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Eye disorders Corneal disorder	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Eye disorders Vision blurred	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Abdominal pain	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Abdominal pain lower	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Abdominal pain upper	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Constipation	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Diarrhoea	36.6% 15/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Duodenal ulcer	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Dyspepsia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Dysphagia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Gastritis	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Nausea	9.8% 4/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	31.7% 13/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Odynophagia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Oesophagitis	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Stomatitis	12.2% 5/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Gastrointestinal disorders Vomiting	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Asthenia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Chills	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Fatigue	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Generalised oedema	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Injection site phlebitis	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Injection site reaction	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Malaise	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Mucosal inflammation	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Non-cardiac chest pain	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Oedema peripheral	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Pain	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Peripheral swelling	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
General disorders Pyrexia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	17.1% 7/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Hepatobiliary disorders Hepatic function abnormal	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Hepatobiliary disorders Liver disorder	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Immune system disorders Hypogammaglobulinaemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Bronchitis	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations COVID-19	26.8% 11/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations COVID-19 pneumonia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Candida infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Conjunctivitis	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Cystitis	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Cytomegalovirus infection	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Cytomegalovirus infection reactivation	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Device related infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Ear infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Gastrointestinal fungal infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Herpes simplex	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Herpes zoster	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Hordeolum	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Infected cyst	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Nail infection	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Pharyngitis	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Pneumocystis jirovecii pneumonia	9.8% 4/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Pneumonia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Pneumonia cytomegaloviral	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Respiratory tract infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Upper respiratory tract infection	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Urinary tract infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Vascular device infection	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Injury, poisoning and procedural complications Chillblains	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Injury, poisoning and procedural complications Contusion	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Injury, poisoning and procedural complications Fall	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Injury, poisoning and procedural complications Heat stroke	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Injury, poisoning and procedural complications Infusion related reaction	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Alanine aminotransferase increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Aspartate aminotransferase increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Beta 2 microglobulin increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Blood creatinine increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Blood uric acid increased	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations C-reactive protein increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Cytomegalovirus test positive	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Ejection fraction decreased	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Electrocardiogram QRS complex prolonged	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Gamma-glutamyltransferase increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Lymphocyte count decreased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Lymphocyte count increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Neutrophil count decreased	24.4% 10/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	17.1% 7/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Platelet count decreased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations Weight decreased	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations White blood cell count decreased	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations White blood cell count increased	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Decreased appetite	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Gout	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hyperglycaemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hyperkalaemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hyperuricaemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hypocalcaemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hypokalaemia	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Hyponatraemia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Impaired fasting glucose	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Malnutrition	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Musculoskeletal and connective tissue disorders Arthritis	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Musculoskeletal and connective tissue disorders Back pain	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Nervous system disorders Dizziness	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Nervous system disorders Dysgeusia	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Nervous system disorders Headache	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Nervous system disorders Neuropathy peripheral	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Nervous system disorders Peripheral sensory neuropathy	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Nervous system disorders Presyncope	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Psychiatric disorders Insomnia	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Renal and urinary disorders Acute kidney injury	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Renal and urinary disorders Hypertonic bladder	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Renal and urinary disorders Nocturia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Renal and urinary disorders Renal failure	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Cough	9.8% 4/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.8% 4/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Respiratory, thoracic and mediastinal disorders Throat irritation	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Dermatitis allergic	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Dry skin	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Rash	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Rash erythematous	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Rash pruritic	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Skin mass	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	7.3% 3/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Vascular disorders Hypertension	4.9% 2/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	0.00% 0/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Infections and infestations Suspected Infection of unknown origin	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.
Investigations AST ALT increase	2.4% 1/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.	14.6% 6/41 • The occurrence of adverse events was assessed for 1 year, 7 months 82 subjects were enrolled and dosed in the trial. 41 subjects in the Rituximab Zandelisib arm and in the R-chemo arm 31 subjects were assigned to R-B and 10 to R-CHOP.

Additional Information

Richard Ghalie, MD CMO

MEI Pharma

Phone: 858.898-0956

Email: rghalie@meipharma.om

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER