Trial Outcomes & Findings for A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor (NCT NCT03235544)
NCT ID: NCT03235544
Last Updated: 2025-03-18
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
162 participants
Primary outcome timeframe
Up to 1016 days
Results posted on
2025-03-18
Participant Flow
Participants took part in the study at 76 investigative sites in France, Spain, the United States, Italy, Poland, Czech Republic, Great Britain, Denmark, Belgium, Germany, and Israel.
A total of 161 participants with relapsed or refractory mantle cell lymphoma who received 1-3 prior systemic therapies were enrolled into 2 Cohorts and treated. An additional participant was enrolled but not treated. Because this participant was not treated, he/she was not assigned to any treatment/cohort and was not included in the "Full Analysis Set" or "Safety Population" for analysis. Cohort 1 had previously received ibrutinib and Cohort 2 were Bruton's tyrosine kinase (BTK) inhibitor naive.
Participant milestones
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
41
|
31
|
77
|
|
Overall Study
COMPLETED
|
1
|
5
|
8
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
36
|
23
|
48
|
Reasons for withdrawal
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Overall Study
Death
|
11
|
31
|
19
|
34
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
5
|
|
Overall Study
Disease Progression
|
0
|
1
|
0
|
2
|
|
Overall Study
Participant Transitioned to Rollover Protocol
|
0
|
0
|
2
|
5
|
|
Overall Study
Discomfort, Pain, and Radiographic Advancement
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Baseline characteristics by cohort
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.2 years
n=5 Participants
|
69.8 years
n=7 Participants
|
72.2 years
n=5 Participants
|
71.5 years
n=4 Participants
|
70.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other" in Database
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 1016 daysPopulation: 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 |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
8.3 percentage of participants
Interval 0.2 to 38.5
|
39.0 percentage of participants
Interval 24.2 to 55.5
|
64.5 percentage of participants
Interval 45.4 to 80.8
|
71.4 percentage of participants
Interval 60.0 to 81.2
|
SECONDARY outcome
Timeframe: Up to 1016 daysPopulation: 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 |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=1 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=16 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=20 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=55 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA months
The median and the lower and upper limits of the 95% confidence interval (CI) were not estimable due to the low number of participants with events of response.
|
3.20 months
Interval 1.87 to 7.95
|
17.45 months
Interval 3.81 to
The upper limit of the 95% CI was not estimable due to the low number of participants with events of response.
|
13.01 months
Interval 9.03 to 16.59
|
SECONDARY outcome
Timeframe: Up to 1016 daysPopulation: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib
CRR is defined as the percentage of participants with a CR as defined by 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 |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Complete Response Rate (CRR)
|
0.0 percentage of participants
Interval 0.0 to 26.5
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
22.6 percentage of participants
Interval 9.6 to 41.1
|
15.6 percentage of participants
Interval 8.3 to 25.6
|
SECONDARY outcome
Timeframe: Up to 1016 daysPopulation: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib
PFS is 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 |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
3.94 months
Interval 1.35 to
The upper limit of the 95% CI was not estimable due to the low number of participants with events.
|
3.68 months
Interval 1.87 to 5.49
|
8.11 months
Interval 5.29 to 21.62
|
13.83 months
Interval 10.02 to 16.89
|
SECONDARY outcome
Timeframe: Up to 2017 daysPopulation: Full Analysis Set
OS is defined as the time from the date of the first dose of study treatment until death from any cause.
Outcome measures
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
10.91 months
Interval 1.35 to 17.64
|
11.01 months
Interval 7.23 to 17.12
|
33.48 months
Interval 21.62 to 54.67
|
45.86 months
Interval 34.2 to
The upper limit of the confidence interval was not estimable because too few participants died.
|
SECONDARY outcome
Timeframe: Up to 1016 daysPopulation: 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 nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Outcome measures
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=6 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=32 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=25 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=68 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Best Percent Change From Baseline in Target Lesion Size
|
-19.82 percent change in lesion size
Standard Deviation 35.926
|
-9.51 percent change in lesion size
Standard Deviation 133.438
|
-64.65 percent change in lesion size
Standard Deviation 53.360
|
-67.54 percent change in lesion size
Standard Deviation 32.918
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 2045 daysPopulation: Safety Population: all enrolled participants who received at least 1 dose of parsaclisib
An adverse event (AE) is 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. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A 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 |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 Participants
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 Participants
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
83.3 percentage of participants
|
90.2 percentage of participants
|
93.5 percentage of participants
|
92.2 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
41.7 percentage of participants
|
48.8 percentage of participants
|
38.7 percentage of participants
|
58.4 percentage of participants
|
Adverse Events
Cohort 1: Treatment A (Exposed to Ibrutinib)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 11 deaths
Cohort 1: Treatment B (Exposed to Ibrutinib)
Serious events: 20 serious events
Other events: 28 other events
Deaths: 31 deaths
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Serious events: 12 serious events
Other events: 27 other events
Deaths: 19 deaths
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Serious events: 45 serious events
Other events: 66 other events
Deaths: 34 deaths
Total
Serious events: 82 serious events
Other events: 130 other events
Deaths: 95 deaths
Serious adverse events
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 participants at risk
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 participants at risk
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 participants at risk
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 participants at risk
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Total
n=161 participants at risk
Total
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.5%
4/161 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukaemia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
COVID-19
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.8%
6/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.0%
8/161 • Number of events 8 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.3%
3/41 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
14.3%
11/77 • Number of events 11 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.3%
15/161 • Number of events 18 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Fatigue
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
General physical health deterioration
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Hyperthermia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.5%
4/161 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Nodule
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Oligoarthritis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.9%
3/161 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.5%
4/161 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Respiratory tract infection
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Sudden death
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Swelling
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Nervous system disorders
Transient ischaemic attack
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
Other adverse events
| Measure |
Cohort 1: Treatment A (Exposed to Ibrutinib)
n=12 participants at risk
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 1: Treatment B (Exposed to Ibrutinib)
n=41 participants at risk
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
|
Cohort 2: Treatment A (BTK Inhibitor Naïve)
n=31 participants at risk
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Cohort 2: Treatment B (BTK Inhibitor Naïve)
n=77 participants at risk
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
|
Total
n=161 participants at risk
Total
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.9%
3/161 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.3%
3/41 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.0%
8/161 • Number of events 8 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
3/12 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
19.5%
8/41 • Number of events 10 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
12.9%
4/31 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.8%
6/77 • Number of events 9 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
13.0%
21/161 • Number of events 27 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.9%
3/161 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.8%
4/41 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
5/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.8%
11/161 • Number of events 12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
5/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Asthenia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
17.1%
7/41 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.7%
3/31 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
14.3%
11/77 • Number of events 14 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
13.0%
21/161 • Number of events 24 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Cardiac disorders
Atrial flutter
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
12.9%
4/31 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.8%
6/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.5%
12/161 • Number of events 12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
5/77 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.6%
9/161 • Number of events 13 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
COVID-19
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.5%
4/161 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.8%
4/41 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.7%
3/31 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
15.6%
12/77 • Number of events 13 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
11.8%
19/161 • Number of events 21 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
12.2%
5/41 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
15.6%
12/77 • Number of events 13 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
12.4%
20/161 • Number of events 21 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.8%
4/41 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.1%
7/77 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
8.7%
14/161 • Number of events 14 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
22.0%
9/41 • Number of events 18 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
25.8%
8/31 • Number of events 11 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
33.8%
26/77 • Number of events 40 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
28.0%
45/161 • Number of events 72 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.3%
3/41 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.7%
3/31 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.8%
11/161 • Number of events 11 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Ear and labyrinth disorders
Ear discomfort
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Eructation
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
5/77 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
10.4%
8/77 • Number of events 8 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
8.7%
14/161 • Number of events 14 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.7%
3/31 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.0%
8/161 • Number of events 9 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.3%
7/161 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.0%
8/161 • Number of events 13 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
15.6%
12/77 • Number of events 16 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
8.1%
13/161 • Number of events 17 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Metabolism and nutrition disorders
Malnutrition
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.0%
8/161 • Number of events 11 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
12.9%
4/31 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
10.4%
8/77 • Number of events 8 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.9%
16/161 • Number of events 17 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
14.6%
6/41 • Number of events 9 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.7%
3/31 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
13.0%
10/77 • Number of events 12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
13.0%
21/161 • Number of events 27 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 9 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.5%
4/161 • Number of events 11 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Oedema peripheral
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.3%
3/41 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
5/77 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.5%
12/161 • Number of events 14 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.8%
6/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.6%
9/161 • Number of events 10 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Pseudomonas test positive
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
14.6%
6/41 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
16.1%
5/31 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
15.6%
12/77 • Number of events 15 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
14.9%
24/161 • Number of events 27 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.8%
4/41 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
20.8%
16/77 • Number of events 19 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
14.3%
23/161 • Number of events 26 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.3%
7/161 • Number of events 7 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 9 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Respiratory rate increased
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.9%
3/161 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.1%
5/161 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.5%
4/161 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Reproductive system and breast disorders
Testicular oedema
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/77 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.62%
1/161 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.3%
3/41 • Number of events 5 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
5/77 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.8%
11/161 • Number of events 14 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.9%
3/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
3.7%
6/161 • Number of events 6 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.4%
1/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.7%
3/31 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
2.6%
2/77 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.3%
7/161 • Number of events 10 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Infections and infestations
Viral infection
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/41 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.3%
1/77 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
1.2%
2/161 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
4.9%
2/41 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.2%
4/77 • Number of events 4 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
5.6%
9/161 • Number of events 9 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
7.3%
3/41 • Number of events 3 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
0.00%
0/31 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
13.0%
10/77 • Number of events 12 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
9.3%
15/161 • Number of events 17 • From first dose of study drug up to 2045 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
|
Additional Information
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