Trial Outcomes & Findings for A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (NCT NCT03126019)

NCT ID: NCT03126019

Last Updated: 2025-03-14

Results Overview

ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node\>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by\>50%in length beyond normal.4.No new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 126 participants
• Primary outcome timeframe: Up to approximately 148 weeks
• Results posted on: 2025-03-14

Participant Flow

Participants took part in the study at 44 investigative sites in the United States, Italy, Spain, Great Britain, Czech Republic, Hungary, Canada, Denmark, Germany, Israel, Poland, and Sweden

A total of 126 participants with relapsed or refractory follicular lymphoma were enrolled in the study and assigned to one of two treatment groups: Treatment A or Treatment B to receive parsaclisib.

Participant milestones

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Overall Study STARTED	23	103
Overall Study COMPLETED	14	50
Overall Study NOT COMPLETED	9	53

Reasons for withdrawal

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Overall Study Death	5	27
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	1	9
Overall Study Physician Decision	1	0
Overall Study Transitioned to Rollover Study	0	11
Overall Study Did Not Return to Site for Care	0	1
Overall Study Site Closed	0	1

Baseline Characteristics

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Baseline characteristics by cohort

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.	Total n=126 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 11.56 • n=5 Participants	67.0 years STANDARD_DEVIATION 10.68 • n=7 Participants	66.5 years STANDARD_DEVIATION 10.86 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	45 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	58 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	90 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race Customized Black/ African- American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race Customized White/ Caucasian	21 Participants n=5 Participants	92 Participants n=7 Participants	113 Participants n=5 Participants
Race Customized Unavailable or Unknown	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 148 weeks

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria	65.2 percentage of participants Interval 42.7 to 83.6	77.7 percentage of participants Interval 68.4 to 85.3

SECONDARY outcome

Timeframe: Up to 1193 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria	17.4 percentage of participants Interval 5.0 to 38.8	22.3 percentage of participants Interval 14.7 to 31.6

SECONDARY outcome

Timeframe: Up to 1193 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed.

DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=15 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=81 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Duration of Response (DOR)	14.06 months Interval 3.19 to The upper limit of the 95% confidence interval (CI) was not estimable due to the low number of participants with events of response.	14.72 months Interval 11.76 to 25.72

SECONDARY outcome

Timeframe: Up to 1193 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Progression-free Survival (PFS) With Parsaclisib	19.32 months Interval 8.31 to 33.15	14.03 months Interval 11.07 to 20.07

SECONDARY outcome

Timeframe: Up to 1193 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

OS was defined as the time from the date of the first dose of study treatment until death from any cause.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Overall Survival (OS) With Parsaclisib	NA months Interval 35.48 to The median and the upper limit of the 95% CI were not estimable due to the low number of participants with events.	NA months The median and the lower and upper limits of the 95% CI were not estimable due to the low number of participants with events.

SECONDARY outcome

Timeframe: Up to 1193 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. The overall number of participants analyzed is the number of participants with data available for analysis.

Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=20 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=98 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Best Percent Change From Baseline in Target Lesion Size	-72.90 percent change in lesion size Standard Deviation 21.782	-72.77 percent change in lesion size Standard Deviation 31.972

SECONDARY outcome

Timeframe: up to approximately 1992 days

Population: Safety Population: all participants enrolled in the study who received at least 1 dose of parsaclisib

An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.

Outcome measures

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 Participants Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 Participants Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	100.0 percentage of participants	99.0 percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	52.2 percentage of participants	53.4 percentage of participants

Adverse Events

Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW

Serious events: 12 serious events

Other events: 22 other events

Deaths: 5 deaths

Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD

Serious events: 55 serious events

Other events: 94 other events

Deaths: 27 deaths

Serious adverse events

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 participants at risk Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 participants at risk Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Renal and urinary disorders Acute kidney injury	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	2.9% 3/103 • Number of events 3 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Blood and lymphatic system disorders Anaemia	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Cardiac disorders Atrial fibrillation	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Autoimmune arthritis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Bacteraemia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations Body temperature increased	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Bursitis infective	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations C-reactive protein increased	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations COVID-19	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Campylobacter colitis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Cerebrovascular accident	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Cervical radiculopathy	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Chest pain	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Colitis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	7.8% 8/103 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Colitis erosive	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Coronavirus infection	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Cytomegalovirus colitis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Vascular disorders Deep vein thrombosis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Dehydration	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Desmoplastic mesothelioma	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	9.7% 10/103 • Number of events 11 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Disease progression	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Diverticular perforation	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Dizziness	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations Electrocardiogram QT prolonged	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Encephalopathy	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Fall	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Gastroenteritis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Gastrointestinal infection	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders General physical health deterioration	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Vascular disorders Haemorrhage	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Headache	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Herpes zoster	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hyperglycaemia	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hyperkalaemia	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Vascular disorders Hypertension	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Vascular disorders Hypotension	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Immune-mediated enterocolitis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Influenza	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Lethargy	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Blood and lymphatic system disorders Leukocytosis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Lower respiratory tract infection	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Mucosal inflammation	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Neck pain	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Nervous system disorder	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations Neutrophil count decreased	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Non-cardiac chest pain	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Oesophageal candidiasis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Oesophagitis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Oral candidiasis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Overdose	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Cardiac disorders Pericardial effusion	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	2.9% 3/103 • Number of events 6 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Pneumonia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	2.9% 3/103 • Number of events 4 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Pyrexia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	2.9% 3/103 • Number of events 3 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Skin and subcutaneous tissue disorders Rash	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Respiratory tract infection	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Cardiac disorders Sinus bradycardia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Stomal hernia	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Stomatitis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Subcutaneous abscess	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Cardiac disorders Supraventricular tachycardia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Urinary tract infection	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Urosepsis	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Ear and labyrinth disorders Vertigo	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Vomiting	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.97% 1/103 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.

Other adverse events

Measure	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW n=23 participants at risk Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD n=103 participants at risk Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	8.7% 9/103 • Number of events 12 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations Alanine aminotransferase increased	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 11 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Blood and lymphatic system disorders Anaemia	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	15.5% 16/103 • Number of events 17 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations Aspartate aminotransferase increased	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	7.8% 8/103 • Number of events 9 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Asthenia	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	13.6% 14/103 • Number of events 17 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	8.7% 9/103 • Number of events 9 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations C-reactive protein increased	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations COVID-19	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	9.7% 10/103 • Number of events 12 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	10.7% 11/103 • Number of events 11 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • Number of events 3 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	27.2% 28/103 • Number of events 30 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Decreased appetite	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	11.7% 12/103 • Number of events 13 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Diarrhoea	13.0% 3/23 • Number of events 5 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	43.7% 45/103 • Number of events 75 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Dizziness	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 7 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	7.8% 8/103 • Number of events 10 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Cardiac disorders Extrasystoles	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Fatigue	13.0% 3/23 • Number of events 3 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	20.4% 21/103 • Number of events 23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Nervous system disorders Headache	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	13.6% 14/103 • Number of events 14 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hyperglycaemia	8.7% 2/23 • Number of events 3 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Vascular disorders Hypertension	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	11.7% 12/103 • Number of events 13 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hypokalaemia	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	12.6% 13/103 • Number of events 16 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	9.7% 10/103 • Number of events 12 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Psychiatric disorders Insomnia	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	5.8% 6/103 • Number of events 6 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	4.9% 5/103 • Number of events 5 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Nausea	34.8% 8/23 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	27.2% 28/103 • Number of events 34 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Blood and lymphatic system disorders Neutropenia	8.7% 2/23 • Number of events 4 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	15.5% 16/103 • Number of events 21 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Oedema peripheral	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	9.7% 10/103 • Number of events 10 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	4.9% 5/103 • Number of events 7 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	7.8% 8/103 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Peripheral swelling	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	1.9% 2/103 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Skin and subcutaneous tissue disorders Pruritus	17.4% 4/23 • Number of events 6 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	2.9% 3/103 • Number of events 5 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
General disorders Pyrexia	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	19.4% 20/103 • Number of events 26 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Skin and subcutaneous tissue disorders Rash	26.1% 6/23 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	14.6% 15/103 • Number of events 18 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 7 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Blood and lymphatic system disorders Thrombocytopenia	4.3% 1/23 • Number of events 1 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 7 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Upper respiratory tract infection	13.0% 3/23 • Number of events 4 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	6.8% 7/103 • Number of events 8 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Infections and infestations Urinary tract infection	13.0% 3/23 • Number of events 3 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	5.8% 6/103 • Number of events 6 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Gastrointestinal disorders Vomiting	13.0% 3/23 • Number of events 4 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	8.7% 9/103 • Number of events 10 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Investigations Weight decreased	0.00% 0/23 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	5.8% 6/103 • Number of events 6 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
Respiratory, thoracic and mediastinal disorders Wheezing	8.7% 2/23 • Number of events 2 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.	0.00% 0/103 • up to approximately 1992 days Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER