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A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor ((CITADEL-205))

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ClinicalTrials.gov Identifier: NCT03235544
Recruitment Status : Active, not recruiting
First Posted : August 1, 2017
Results First Posted : February 10, 2022
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Drug: Parsaclisib
Enrollment 162
Recruitment Details 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. Data are reported up to primary completion date, 3 March 2021. This study is ongoing.
Pre-assignment Details 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.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, 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.
Period Title: Overall Study
Started 12 41 31 77
Completed 0 0 0 0
Not Completed 12 41 31 77
Reason Not Completed
Participants Still Ongoing in the Study             1             13             19             55
Death             11             23             11             20
Lost to Follow-up             0             1             0             1
Withdrawal by Participant             0             0             1             0
Reason not Specified             0             4             0             1
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve) Total
Hide Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, 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 of all reporting groups
Overall Number of Baseline Participants 12 41 31 77 161
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 41 participants 31 participants 77 participants 161 participants
70.2
(53 to 82)
69.8
(48 to 89)
72.2
(43 to 89)
71.5
(51 to 90)
70.9
(43 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 41 participants 31 participants 77 participants 161 participants
Female
1
   8.3%
11
  26.8%
5
  16.1%
17
  22.1%
34
  21.1%
Male
11
  91.7%
30
  73.2%
26
  83.9%
60
  77.9%
127
  78.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 41 participants 31 participants 77 participants 161 participants
Hispanic or Latino
3
  25.0%
2
   4.9%
4
  12.9%
5
   6.5%
14
   8.7%
Not Hispanic or Latino
6
  50.0%
28
  68.3%
21
  67.7%
57
  74.0%
112
  69.6%
Not Reported
1
   8.3%
5
  12.2%
6
  19.4%
8
  10.4%
20
  12.4%
Unknown
2
  16.7%
4
   9.8%
0
   0.0%
1
   1.3%
7
   4.3%
Other
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.6%
2
   1.2%
Missing
0
   0.0%
2
   4.9%
0
   0.0%
4
   5.2%
6
   3.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 41 participants 31 participants 77 participants 161 participants
White
11
  91.7%
37
  90.2%
24
  77.4%
64
  83.1%
136
  84.5%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.6%
2
   1.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.6%
American-Indian/Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian/Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
1
   8.3%
1
   2.4%
5
  16.1%
3
   3.9%
10
   6.2%
Missing
0
   0.0%
3
   7.3%
2
   6.5%
7
   9.1%
12
   7.5%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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.
Time Frame Up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 12 41 31 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(0.2 to 38.5)
36.6
(22.1 to 53.1)
64.5
(45.4 to 80.8)
70.1
(58.6 to 80.0)
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description 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.
Time Frame Up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed for this outcome measure.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 1 15 20 54
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
3.71
(1.87 to 7.95)
17.45 [2] 
(3.81 to NA)
12.09 [2] 
(9.03 to NA)
[1]
The median, lower and upper limits of 95% confidence interval (CI) were not estimable due to low number of participants with event.
[2]
The upper limit of 95% CI was not estimable due to low number of participants with event.
3.Secondary Outcome
Title Complete Response Rate (CRR)
Hide Description 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.
Time Frame Up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 12 41 31 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 26.5)
2.4
(0.1 to 12.9)
22.6
(9.6 to 41.1)
15.6
(8.3 to 25.6)
4.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Time Frame Up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 12 41 31 77
Median (95% Confidence Interval)
Unit of Measure: months
3.94 [1] 
(1.35 to NA)
3.68
(1.87 to 4.14)
8.11
(5.29 to 21.62)
13.60
(10.02 to 16.89)
[1]
The upper limit of 95% CI was not estimable due to low number of participants with event.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the date of the first dose of study treatment until death from any cause.
Time Frame Up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 12 41 31 77
Median (95% Confidence Interval)
Unit of Measure: months
10.91
(1.35 to 17.64)
11.01
(7.92 to 18.40)
NA [1] 
(21.62 to NA)
NA [1] 
(24.44 to NA)
[1]
The median, and upper limit of 95% CI were not estimable due to low number of participants with event.
6.Secondary Outcome
Title Best Percent Change From Baseline in Target Lesion Size
Hide Description 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.
Time Frame Up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Overall number analyzed are the number of participants with data available for analyses.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 6 31 25 69
Mean (Standard Deviation)
Unit of Measure: percent change in lesion size
-19.82  (35.926) -7.41  (135.103) -64.49  (53.354) -67.61  (32.222)
7.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From first dose of study drug up to approximately 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
Hide Arm/Group Description:
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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.
Participants received parsaclisib 20 mg tablets, 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 Number of Participants Analyzed 12 41 31 77
Measure Type: Number
Unit of Measure: percentage of participants
TEAEs 83.3 87.8 93.5 89.6
SAEs 41.7 41.5 35.5 45.5
Time Frame From first dose of study drug up to approximately 182 weeks (up to data cut-off: 14 May 2021)
Adverse Event Reporting Description Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.
 
Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
Hide Arm/Group Description Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, 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. Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group. Participants received parsaclisib 20 mg tablets, 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
All-Cause Mortality
Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)      23/41 (56.10%)      11/31 (35.48%)      20/77 (25.97%)      65/161 (40.37%)    
Hide Serious Adverse Events
Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      17/41 (41.46%)      11/31 (35.48%)      35/77 (45.45%)      68/161 (42.24%)    
Blood and lymphatic system disorders           
Febrile neutropenia † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Leukocytosis † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Neutropenia † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 2/161 (1.24%)  2
Cardiac disorders           
Arrhythmia supraventricular † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Atrial fibrillation † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Cardiac failure † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Gastrointestinal disorders           
Abdominal pain † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Abdominal pain upper † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Ascites † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Autoimmune colitis † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Colitis † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 0/31 (0.00%)  0 5/77 (6.49%)  5 7/161 (4.35%)  7
Diarrhoea † 1  1/12 (8.33%)  1 3/41 (7.32%)  6 0/31 (0.00%)  0 10/77 (12.99%)  10 14/161 (8.70%)  17
Gastrointestinal haemorrhage † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Incarcerated inguinal hernia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Intestinal perforation † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Nausea † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Oesophagitis ulcerative † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Vomiting † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
General disorders           
Fatigue † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
General physical health deterioration † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Hyperthermia † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Nodule † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Peripheral swelling † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 2/161 (1.24%)  2
Pyrexia † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 1/31 (3.23%)  1 2/77 (2.60%)  2 4/161 (2.48%)  4
Sudden death † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Swelling † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Hepatobiliary disorders           
Hepatocellular injury † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Infections and infestations           
Atypical pneumonia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Bacteraemia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Bronchitis † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Clostridium difficile colitis † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Cytomegalovirus colitis † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Cytomegalovirus infection † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Cytomegalovirus infection reactivation † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Endocarditis staphylococcal † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Infection † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Parainfluenzae virus infection † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Pneumocystis jirovecii pneumonia † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 2/161 (1.24%)  2
Pneumonia † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 0/31 (0.00%)  0 1/77 (1.30%)  1 3/161 (1.86%)  3
Pneumonia pneumococcal † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  2 1/161 (0.62%)  2
Respiratory tract infection † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Septic shock † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 1/77 (1.30%)  1 2/161 (1.24%)  2
Upper respiratory tract infection † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Urinary tract infection † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Urosepsis † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Injury, poisoning and procedural complications           
Accidental overdose † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Spinal fracture † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Investigations           
Alanine aminotransferase increased † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Aspartate aminotransferase increased † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Eastern Cooperative Oncology Group performance status worsened † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Metabolism and nutrition disorders           
Dehydration † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 2/161 (1.24%)  2
Diabetic metabolic decompensation † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Hyperuricaemia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Hypokalaemia † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 1/31 (3.23%)  1 2/77 (2.60%)  2 4/161 (2.48%)  4
Musculoskeletal and connective tissue disorders           
Back pain † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Pain in extremity † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Spondylitis † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Acute myelomonocytic leukaemia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Mantle cell lymphoma † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Nervous system disorders           
Epilepsy † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Ischaemic stroke † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Transient ischaemic attack † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Renal and urinary disorders           
Acute kidney injury † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 1/77 (1.30%)  1 2/161 (1.24%)  2
Renal failure † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Dyspnoea † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 2/161 (1.24%)  2
Dyspnoea exertional † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Lung disorder † 1  0/12 (0.00%)  0 1/41 (2.44%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  2
Pulmonary embolism † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 1/77 (1.30%)  1 2/161 (1.24%)  2
Skin and subcutaneous tissue disorders           
Dermatitis exfoliative † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Dermatitis psoriasiform † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Drug reaction with eosinophilia and systemic symptoms † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 1/161 (0.62%)  1
Eczema † 1  0/12 (0.00%)  0 1/41 (2.44%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  2
Rash † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 0/31 (0.00%)  0 2/77 (2.60%)  2 2/161 (1.24%)  2
Vascular disorders           
Deep vein thrombosis † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 1/161 (0.62%)  1
Hypotension † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 1/77 (1.30%)  1 2/161 (1.24%)  2
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/12 (75.00%)      28/41 (68.29%)      26/31 (83.87%)      61/77 (79.22%)      124/161 (77.02%)    
Blood and lymphatic system disorders           
Anaemia † 1  3/12 (25.00%)  4 8/41 (19.51%)  10 3/31 (9.68%)  3 6/77 (7.79%)  9 20/161 (12.42%)  26
Eosinophilia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 2/31 (6.45%)  2 2/77 (2.60%)  2 4/161 (2.48%)  4
Neutropenia † 1  2/12 (16.67%)  2 5/41 (12.20%)  8 3/31 (9.68%)  4 9/77 (11.69%)  10 19/161 (11.80%)  24
Thrombocytopenia † 1  1/12 (8.33%)  1 3/41 (7.32%)  5 2/31 (6.45%)  2 5/77 (6.49%)  6 11/161 (6.83%)  14
Cardiac disorders           
Atrial flutter † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Tachycardia † 1  1/12 (8.33%)  1 2/41 (4.88%)  2 0/31 (0.00%)  0 1/77 (1.30%)  1 4/161 (2.48%)  4
Ear and labyrinth disorders           
Ear discomfort † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Vertigo † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 2/161 (1.24%)  2
Gastrointestinal disorders           
Abdominal distension † 1  1/12 (8.33%)  1 1/41 (2.44%)  1 0/31 (0.00%)  0 1/77 (1.30%)  1 3/161 (1.86%)  3
Abdominal pain † 1  0/12 (0.00%)  0 3/41 (7.32%)  3 1/31 (3.23%)  1 3/77 (3.90%)  3 7/161 (4.35%)  7
Colitis † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 2/77 (2.60%)  2 3/161 (1.86%)  3
Constipation † 1  0/12 (0.00%)  0 4/41 (9.76%)  5 3/31 (9.68%)  3 11/77 (14.29%)  12 18/161 (11.18%)  20
Diarrhoea † 1  2/12 (16.67%)  3 10/41 (24.39%)  14 6/31 (19.35%)  8 23/77 (29.87%)  31 41/161 (25.47%)  56
Dyspepsia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 2/31 (6.45%)  2 2/77 (2.60%)  2 4/161 (2.48%)  4
Dysphagia † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 2/31 (6.45%)  2 1/77 (1.30%)  1 5/161 (3.11%)  5
Eructation † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Nausea † 1  2/12 (16.67%)  2 2/41 (4.88%)  3 4/31 (12.90%)  4 6/77 (7.79%)  6 14/161 (8.70%)  15
Stomatitis † 1  1/12 (8.33%)  1 1/41 (2.44%)  1 1/31 (3.23%)  1 2/77 (2.60%)  2 5/161 (3.11%)  5
Vomiting † 1  1/12 (8.33%)  1 3/41 (7.32%)  3 1/31 (3.23%)  1 2/77 (2.60%)  2 7/161 (4.35%)  7
General disorders           
Asthenia † 1  0/12 (0.00%)  0 8/41 (19.51%)  8 2/31 (6.45%)  2 10/77 (12.99%)  11 20/161 (12.42%)  21
Fatigue † 1  2/12 (16.67%)  2 2/41 (4.88%)  2 2/31 (6.45%)  2 8/77 (10.39%)  8 14/161 (8.70%)  14
Oedema peripheral † 1  2/12 (16.67%)  3 3/41 (7.32%)  4 2/31 (6.45%)  2 4/77 (5.19%)  4 11/161 (6.83%)  13
Pyrexia † 1  1/12 (8.33%)  1 5/41 (12.20%)  5 5/31 (16.13%)  5 11/77 (14.29%)  14 22/161 (13.66%)  25
Infections and infestations           
Nasopharyngitis † 1  2/12 (16.67%)  3 1/41 (2.44%)  2 2/31 (6.45%)  2 2/77 (2.60%)  2 7/161 (4.35%)  9
Rhinitis † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 2/31 (6.45%)  2 0/77 (0.00%)  0 3/161 (1.86%)  3
Upper respiratory tract infection † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 2/31 (6.45%)  2 2/77 (2.60%)  2 5/161 (3.11%)  5
Urinary tract infection † 1  1/12 (8.33%)  1 1/41 (2.44%)  2 3/31 (9.68%)  4 2/77 (2.60%)  2 7/161 (4.35%)  9
Viral infection † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 1/77 (1.30%)  1 2/161 (1.24%)  2
Investigations           
Blood creatinine increased † 1  0/12 (0.00%)  0 2/41 (4.88%)  3 2/31 (6.45%)  2 5/77 (6.49%)  5 9/161 (5.59%)  10
Neutrophil count decreased † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 2/31 (6.45%)  2 2/77 (2.60%)  7 4/161 (2.48%)  9
Platelet count decreased † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 2/31 (6.45%)  2 2/77 (2.60%)  2 5/161 (3.11%)  5
Pseudomonas test positive † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Respiratory rate increased † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Weight decreased † 1  2/12 (16.67%)  2 4/41 (9.76%)  4 0/31 (0.00%)  0 7/77 (9.09%)  8 13/161 (8.07%)  14
Metabolism and nutrition disorders           
Decreased appetite † 1  2/12 (16.67%)  2 4/41 (9.76%)  4 0/31 (0.00%)  0 6/77 (7.79%)  6 12/161 (7.45%)  12
Hyperkalaemia † 1  1/12 (8.33%)  1 1/41 (2.44%)  1 0/31 (0.00%)  0 0/77 (0.00%)  0 2/161 (1.24%)  2
Hypernatraemia † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Hyperuricaemia † 1  1/12 (8.33%)  1 2/41 (4.88%)  4 2/31 (6.45%)  2 3/77 (3.90%)  5 8/161 (4.97%)  12
Hypokalaemia † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 8/77 (10.39%)  11 9/161 (5.59%)  12
Hypophosphataemia † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 2/31 (6.45%)  2 1/77 (1.30%)  1 4/161 (2.48%)  4
Malnutrition † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  0/12 (0.00%)  0 4/41 (9.76%)  4 2/31 (6.45%)  2 5/77 (6.49%)  5 11/161 (6.83%)  11
Back pain † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 4/31 (12.90%)  4 6/77 (7.79%)  6 12/161 (7.45%)  12
Muscle spasms † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 2/31 (6.45%)  2 2/77 (2.60%)  2 6/161 (3.73%)  6
Myalgia † 1  0/12 (0.00%)  0 0/41 (0.00%)  0 1/31 (3.23%)  2 4/77 (5.19%)  4 5/161 (3.11%)  6
Pain in extremity † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 2/31 (6.45%)  2 2/77 (2.60%)  3 6/161 (3.73%)  7
Nervous system disorders           
Headache † 1  2/12 (16.67%)  2 2/41 (4.88%)  2 3/31 (9.68%)  4 1/77 (1.30%)  1 8/161 (4.97%)  9
Psychiatric disorders           
Anxiety † 1  1/12 (8.33%)  1 2/41 (4.88%)  2 0/31 (0.00%)  0 0/77 (0.00%)  0 3/161 (1.86%)  3
Insomnia † 1  2/12 (16.67%)  2 1/41 (2.44%)  1 0/31 (0.00%)  0 3/77 (3.90%)  3 6/161 (3.73%)  6
Renal and urinary disorders           
Renal failure † 1  2/12 (16.67%)  2 1/41 (2.44%)  2 0/31 (0.00%)  0 3/77 (3.90%)  5 6/161 (3.73%)  9
Reproductive system and breast disorders           
Testicular oedema † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 0/31 (0.00%)  0 0/77 (0.00%)  0 1/161 (0.62%)  1
Respiratory, thoracic and mediastinal disorders           
Cough † 1  1/12 (8.33%)  1 5/41 (12.20%)  5 2/31 (6.45%)  2 9/77 (11.69%)  10 17/161 (10.56%)  18
Dyspnoea † 1  1/12 (8.33%)  1 3/41 (7.32%)  3 3/31 (9.68%)  3 2/77 (2.60%)  2 9/161 (5.59%)  9
Skin and subcutaneous tissue disorders           
Erythema † 1  0/12 (0.00%)  0 1/41 (2.44%)  1 0/31 (0.00%)  0 5/77 (6.49%)  5 6/161 (3.73%)  6
Hyperhidrosis † 1  1/12 (8.33%)  1 0/41 (0.00%)  0 1/31 (3.23%)  1 0/77 (0.00%)  0 2/161 (1.24%)  2
Pruritus † 1  1/12 (8.33%)  1 1/41 (2.44%)  2 0/31 (0.00%)  0 5/77 (6.49%)  5 7/161 (4.35%)  8
Rash † 1  1/12 (8.33%)  1 4/41 (9.76%)  4 1/31 (3.23%)  1 11/77 (14.29%)  13 17/161 (10.56%)  19
Rash maculo-papular † 1  0/12 (0.00%)  0 2/41 (4.88%)  2 2/31 (6.45%)  2 3/77 (3.90%)  3 7/161 (4.35%)  7
Vascular disorders           
Hypertension † 1  1/12 (8.33%)  1 1/41 (2.44%)  1 0/31 (0.00%)  0 4/77 (5.19%)  4 6/161 (3.73%)  6
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 1-855-463-3463
EMail: medinfo@incyte.com
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03235544    
Other Study ID Numbers: INCB 50465-205 (CITADEL-205)
Parsaclisib ( Other Identifier: Incyte Corporation )
2017-003148-19 ( EudraCT Number )
First Submitted: July 27, 2017
First Posted: August 1, 2017
Results First Submitted: January 14, 2022
Results First Posted: February 10, 2022
Last Update Posted: November 18, 2023