Trial Outcomes & Findings for A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma (NCT NCT04038359)

Last Updated: 2024-09-19

Results Overview

ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

Up to 14 months

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Duvelisib, Continuous and Intermittent Dosing Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Overall Study STARTED	52	51
Overall Study Received At Least 1 Dose of Study Drug	51	51
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	20	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Duvelisib, Continuous and Intermittent Dosing Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Overall Study Consent Withdrawn Prior to Receiving Study Drug	1	0
Overall Study Death	8	7
Overall Study Lost to Follow-up	3	0
Overall Study Participant Moved	1	0
Overall Study Withdrawal by Subject	4	3
Overall Study Physician Decision	3	2
Overall Study Adverse Event	0	2
Overall Study Progressive Disease	0	1

Baseline Characteristics

A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duvelisib, Continuous and Intermittent Dosing n=51 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.	Total n=102 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 12.15 • n=99 Participants	63.9 years STANDARD_DEVIATION 11.40 • n=107 Participants	62.2 years STANDARD_DEVIATION 11.85 • n=206 Participants
Sex: Female, Male Female	28 Participants n=99 Participants	27 Participants n=107 Participants	55 Participants n=206 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	24 Participants n=107 Participants	47 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=99 Participants	50 Participants n=107 Participants	98 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	14 Participants n=99 Participants	9 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	36 Participants n=99 Participants	42 Participants n=107 Participants	78 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Per-protocol (PP) Analysis Set: all participants in the mITT analysis set who did not violate the protocol in a way that would significantly affect the study outcome. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria mITT	65.3 percentage of participants Interval 50.4 to 78.3	52.9 percentage of participants Interval 38.5 to 67.1
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria PP	62.2 percentage of participants Interval 46.5 to 76.2	54.3 percentage of participants Interval 39.0 to 69.1

SECONDARY outcome

Timeframe: Up to 2 years

Population: Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography \[PET-CT\]) and progressive disease (according to computed tomography \[CT\]). Results reported as months.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Progression-free Survival (PFS) 2007 Revised IWG Criteria	16.0 months Interval 8.5 to 27.2	23.0 months Interval 12.5 to 34.3
Progression-free Survival (PFS) 2014 Lugano Criteria	16.0 months Interval 8.5 to 27.2	23.0 months Interval 12.5 to 34.3

SECONDARY outcome

Timeframe: 6, 12, 18, and 24 months after first dose of study intervention

ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
ORR At Specific Timepoints 18 months: 2014 Lugano Criteria	65.3 percentage of participants Interval 50.4 to 78.3	51.0 percentage of participants Interval 36.6 to 65.2
ORR At Specific Timepoints 24 months: 2014 Lugano Criteria	65.3 percentage of participants Interval 50.4 to 78.3	51.0 percentage of participants Interval 36.6 to 65.2
ORR At Specific Timepoints 6 months: 2007 Revised IWG Criteria	63.3 percentage of participants Interval 48.3 to 76.6	49.0 percentage of participants Interval 34.8 to 63.4
ORR At Specific Timepoints 12 months: 2007 Revised IWG Criteria	65.3 percentage of participants Interval 50.4 to 78.3	52.9 percentage of participants Interval 38.5 to 67.1
ORR At Specific Timepoints 18 months: 2007 Revised IWG Criteria	65.3 percentage of participants Interval 50.4 to 78.3	52.9 percentage of participants Interval 38.5 to 67.1
ORR At Specific Timepoints 24 months: 2007 Revised IWG Criteria	65.3 percentage of participants Interval 50.4 to 78.3	52.9 percentage of participants Interval 38.5 to 67.1
ORR At Specific Timepoints 6 months: 2014 Lugano Criteria	63.3 percentage of participants Interval 48.3 to 76.6	47.1 percentage of participants Interval 32.9 to 61.5
ORR At Specific Timepoints 12 months: 2014 Lugano Criteria	65.3 percentage of participants Interval 50.4 to 78.3	51.0 percentage of participants Interval 36.6 to 65.2

SECONDARY outcome

Timeframe: Up to 2 years

DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Duration of Response (DOR) 2007 Revised IWG Criteria	21.4 months Interval 13.7 to Insufficient number of participants with events.	32.2 months Interval 17.5 to Insufficient number of participants with events.
Duration of Response (DOR) 2014 Lugano Criteria	21.4 months Interval 13.7 to Insufficient number of participants with events.	32.2 months Interval 13.8 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 2 years

OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Overall Survival (OS)	NA months Insufficient number of participants with events.	NA months Insufficient number of participants with events.

SECONDARY outcome

Timeframe: 14 months

LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Lymph Node Response Rate (LNRR)	64.3 percentage of participants Interval 48.0 to 78.4	60.9 percentage of participants Interval 45.4 to 74.9

SECONDARY outcome

Timeframe: Up to 14 months

Population: Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure.

For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Time To First Response (TTFR) 2014 Lugano Criteria	2.30 months Interval 2.1 to 12.9	2.30 months Interval 2.1 to 12.5
Time To First Response (TTFR) 2007 Revised IWG Criteria	2.30 months Interval 2.1 to 12.9	2.30 months Interval 2.1 to 12.5

SECONDARY outcome

Timeframe: Up to 2 years

TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Time To Treatment Failure (TTF)	12.6 months Interval 6.2 to 17.1	14.3 months Interval 8.0 to 23.0

SECONDARY outcome

Timeframe: Up to 14 months

ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).

Outcome measures

Outcome measures
Measure	Duvelisib, Continuous and Intermittent Dosing n=49 Participants Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 Participants Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
ORR According to 2014 Lugano Criteria PP	62.2 percentage of participants Interval 46.5 to 76.2	52.2 percentage of participants Interval 36.9 to 67.1
ORR According to 2014 Lugano Criteria mITT	65.3 percentage of participants Interval 50.4 to 78.3	51.0 percentage of participants Interval 36.6 to 65.2

Adverse Events

Duvelisib, Continuous and Intermittent Dosing

Serious events: 13 serious events

Other events: 49 other events

Deaths: 8 deaths

Duvelisib, Intermittent Dosing

Serious events: 16 serious events

Other events: 50 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Ohad Bentur, MD, MHA, MSc

Secura Bio, Inc.

Phone: 1-702-254-0011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Duvelisib, Continuous and Intermittent Dosing n=51 participants at risk Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 participants at risk Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Blood and lymphatic system disorders Febrile neutropenia	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Blood and lymphatic system disorders Anaemia	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Cardiac disorders Cardiac arrest	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Cardiac disorders Cardiac failure	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Cardiac disorders Myocardial infarction	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Pylorospasm	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Ascites	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Diarrhoea	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
General disorders Disease progression	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
General disorders Asthenia	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
General disorders Oedema peripheral	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations COVID-19 pneumonia	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations COVID-19	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Cellulitis	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Gangrene	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Osteomyelitis	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Pneumonia	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Sepsis	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Influenza	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Septic shock	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Injury, poisoning and procedural complications Overdose	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Nervous system disorders Cerebrovascular accident	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Psychiatric disorders Major depression	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Vascular disorders Pelvic venous thrombosis	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.

Measure	Duvelisib, Continuous and Intermittent Dosing n=51 participants at risk Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.	Duvelisib, Intermittent Dosing n=51 participants at risk Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Blood and lymphatic system disorders Anaemia	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Blood and lymphatic system disorders Neutropenia	19.6% 10/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	33.3% 17/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Blood and lymphatic system disorders Thrombocytopenia	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Abdominal pain	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Constipation	11.8% 6/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Diarrhoea	33.3% 17/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	19.6% 10/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Dyspepsia	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Nausea	13.7% 7/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	15.7% 8/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Stomatitis	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Gastrointestinal disorders Vomiting	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
General disorders Asthenia	11.8% 6/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
General disorders Fatigue	13.7% 7/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
General disorders Pyrexia	17.6% 9/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	17.6% 9/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations COVID-19	15.7% 8/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	19.6% 10/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Pneumonia	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Upper respiratory tract infection	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Infections and infestations Urinary tract infection	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Investigations Alanine aminotransferase increased	29.4% 15/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	15.7% 8/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Investigations Aspartate aminotransferase increased	29.4% 15/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	11.8% 6/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Investigations Neutrophil count decreased	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Investigations Platelet count decreased	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Investigations Weight decreased	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Metabolism and nutrition disorders Decreased appetite	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Metabolism and nutrition disorders Hyperkalaemia	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 5/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Musculoskeletal and connective tissue disorders Pain in extremity	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Nervous system disorders Dizziness	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Nervous system disorders Headache	15.7% 8/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	2.0% 1/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Psychiatric disorders Insomnia	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Skin and subcutaneous tissue disorders Pruritus	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Skin and subcutaneous tissue disorders Rash	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	11.8% 6/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	5.9% 3/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Skin and subcutaneous tissue disorders Urticaria	7.8% 4/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	3.9% 2/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
Vascular disorders Hypertension	0.00% 0/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.	11.8% 6/51 • Up to 37 months All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.