Trial Outcomes & Findings for A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202) (NCT NCT02998476)
NCT ID: NCT02998476
Last Updated: 2025-08-22
Results Overview
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Results posted on
2025-08-22
Participant Flow
A Phase 2, multicenter, international, open-label study with approximately 120 planned participants with relapsed or refractory DLBCL.
55 participants included in the treatment group A who were not previously treated with a BTK inhibitor and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW. 5 Participants were enrolled in group B who were previously treated with a BTK inhibitor. and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW.
Participant milestones
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
55
|
5
|
Reasons for withdrawal
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Participants transferred to rollover study INCB50465-801
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Death
|
45
|
2
|
|
Overall Study
Other
|
6
|
1
|
Baseline Characteristics
A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Baseline characteristics by cohort
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 Participants
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
n=5 Participants
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 12.97 • n=7 Participants
|
69.5 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
42 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
ECOG
0
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ECOG
1
|
34 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
ECOG
2
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 monthsPopulation: The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
Outcome measures
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 Participants
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Objective Response Rate Based on Lugano Classification Criteria in Group A
|
25.5 percentage
Interval 14.7 to 39.0
|
—
|
SECONDARY outcome
Timeframe: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 monthsPopulation: The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
Outcome measures
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 Participants
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Duration of Response in Group A
|
6.2 months
Interval 2.1 to
The upper boundary of the 95% CI was not reached
|
—
|
SECONDARY outcome
Timeframe: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 monthsPopulation: The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
Outcome measures
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 Participants
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Progression-free Survival in Group A
|
2.2 months
Interval 2.0 to 4.1
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until death by any cause; up to 26 monthsPopulation: The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
Defined as the time from the date of the first dose of study drug until death by any cause.
Outcome measures
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 Participants
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Overall Survival (OS) in Group A
|
7.0 months
Interval 3.5 to
The upper boundary of the 95% CI was not reached
|
—
|
SECONDARY outcome
Timeframe: Screening through 35 days after end of treatment, up to 42 monthsA TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.
Outcome measures
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 Participants
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
n=5 Participants
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
|---|---|---|
|
Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
|
50 Participants
|
4 Participants
|
Adverse Events
Group A Parsaclisib (no Prior BTK Inhibitor)
Serious events: 39 serious events
Other events: 41 other events
Deaths: 45 deaths
Group B Parsaclisib (Prior BTK Inhibitor)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Total
Serious events: 41 serious events
Other events: 44 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 participants at risk
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
n=5 participants at risk
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
Total
n=60 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
2/55 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Asthenia
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Chest pain
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Dizziness
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Fatigue
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
2/55 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
General physical health deterioration
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Renal and urinary disorders
Hydronephrosis
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.3%
4/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Vascular disorders
Hypotension
|
1.8%
1/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Oesophageal candidiasis
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Vascular disorders
Orthostatic hypotension
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Cardiac disorders
Pericarditis
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Pneumonia bacterial
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Presyncope
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Pyrexia
|
9.1%
5/55 • Number of events 8 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
8.3%
5/60 • Number of events 8 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.6%
2/55 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Septic shock
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Syncope
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Urinary tract infection
|
3.6%
2/55 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Urosepsis
|
3.6%
2/55 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
Other adverse events
| Measure |
Group A Parsaclisib (no Prior BTK Inhibitor)
n=55 participants at risk
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
|
Group B Parsaclisib (Prior BTK Inhibitor)
n=5 participants at risk
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
|
Total
n=60 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
4/55 • Number of events 6 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 6 • Screening through 35 days after end of treatment, up to 42 months
|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
4/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Psychiatric disorders
Anxiety
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Chills
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Constipation
|
9.1%
5/55 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
8.3%
5/60 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.4%
9/55 • Number of events 10 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
15.0%
9/60 • Number of events 10 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
5/55 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
8.3%
5/60 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
10/55 • Number of events 11 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
16.7%
10/60 • Number of events 11 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.7%
7/55 • Number of events 7 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
13.3%
8/60 • Number of events 9 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Injury, poisoning and procedural complications
Fall
|
7.3%
4/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Fatigue
|
7.3%
4/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
8.3%
5/60 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
General physical health deterioration
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Headache
|
5.5%
3/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
3/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.5%
3/55 • Number of events 6 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 6 • Screening through 35 days after end of treatment, up to 42 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
11/55 • Number of events 11 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
18.3%
11/60 • Number of events 11 • Screening through 35 days after end of treatment, up to 42 months
|
|
Investigations
Neutrophil count decreased
|
9.1%
5/55 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
8.3%
5/60 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Non-cardiac chest pain
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Oedema peripheral
|
7.3%
4/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
3/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
|
General disorders
Pyrexia
|
9.1%
5/55 • Number of events 7 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
8.3%
5/60 • Number of events 7 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
2/55 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
5.0%
3/60 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
40.0%
2/5 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/55 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
1.7%
1/60 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
|
Infections and infestations
Urinary tract infection
|
7.3%
4/55 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.8%
1/55 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
3.3%
2/60 • Number of events 2 • Screening through 35 days after end of treatment, up to 42 months
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
4/55 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
0.00%
0/5 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 5 • Screening through 35 days after end of treatment, up to 42 months
|
|
Investigations
Weight decreased
|
5.5%
3/55 • Number of events 3 • Screening through 35 days after end of treatment, up to 42 months
|
20.0%
1/5 • Number of events 1 • Screening through 35 days after end of treatment, up to 42 months
|
6.7%
4/60 • Number of events 4 • Screening through 35 days after end of treatment, up to 42 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER