Trial Outcomes & Findings for A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) (NCT NCT04809467)
NCT ID: NCT04809467
Last Updated: 2026-02-04
Results Overview
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
up to 1092 days
Results posted on
2026-02-04
Participant Flow
Participants were enrolled across 16 sites in Austria, Belgium, Spain, France, and Italy. Enrollment was not fully completed due to a strategic decision by the sponsor to discontinue further enrollment in the study based on the changing treatment landscape with respect to the use of PI3Kδ inhibitors (including but not limited to parsaclisib) for treatment of NHL. Therefore the expansion phase was not opened.
Participant milestones
| Measure |
Cohort 1: R/R DLBCL
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
21
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
21
|
3
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: R/R DLBCL
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
9
|
7
|
4
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
1
|
0
|
|
Overall Study
Sponsor Terminated Collection of Follow-up Data
|
3
|
2
|
10
|
1
|
2
|
|
Overall Study
Medical Decision Due to Worsening Clinical Condition
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Transitioned to Rollover Protocol
|
0
|
1
|
2
|
0
|
1
|
|
Overall Study
Withdrawal per Principal Investigator; New Treatment
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Cohort 2: R/R MCL
n=11 Participants
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 1: R/R DLBCL
n=15 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 Participants
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 Participants
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 Participants
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 15.06 • n=1581 Participants
|
67.2 years
STANDARD_DEVIATION 15.47 • n=41 Participants
|
66.8 years
STANDARD_DEVIATION 8.03 • n=4626 Participants
|
65.7 years
STANDARD_DEVIATION 17.21 • n=72 Participants
|
70.3 years
STANDARD_DEVIATION 5.74 • n=11 Participants
|
67.5 years
STANDARD_DEVIATION 12.03 • n=19 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1581 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
2 Participants
n=11 Participants
|
22 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=1581 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=11 Participants
|
32 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=1581 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
7 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=1581 Participants
|
13 Participants
n=41 Participants
|
16 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
2 Participants
n=11 Participants
|
39 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1581 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=11 Participants
|
8 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=1581 Participants
|
14 Participants
n=41 Participants
|
18 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
3 Participants
n=11 Participants
|
47 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1581 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=11 Participants
|
7 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: up to 1092 daysPopulation: Full Analysis Set: all participants who received at least 1 dose of tafasitamab or parsaclisib
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=15 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
n=11 Participants
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 Participants
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 Participants
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 Participants
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE )
|
15 Participants
|
11 Participants
|
21 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: up to 1092 daysPopulation: Full Analysis Set
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=15 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
n=11 Participants
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 Participants
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 Participants
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 Participants
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE
|
12 Participants
|
9 Participants
|
18 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: up to 28 daysPopulation: Dose-limiting Toxicity Evaluable Population: all participants who received at least 3 of 4 doses of tafasitamab and 21 days of treatment with parsaclisib 20 mg QD during the first cycle (28 days) or experienced a DLT
A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=15 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
n=11 Participants
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 Participants
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 Participants
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 Participants
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 1002 daysPopulation: Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
Lugano complete response/complete metabolic response (CR/CMR): target nodes/masses of lymph nodes/extralymphatic sites (LNs/ELSs) regressed to ≤1.5 cm; no non-measured lesions; organ enlargement regressed to normal; no new lesions (NNLs); normal bone marrow. Lugano partial response/partial metabolic response (PR/PMR): LNs/ELSs, ≥50% decrease in the product of perpendicular diameters sum for multiple lesions; no/regressed non-measured lesions, no increase; organ enlargement; NNLs. iwCLL CR: no LNs ≥1.5 cm; spleen size \<13 cm/liver size normal; no constitutional symptoms; normal circulating lymphocyte count (CLC); ≥100 × 10\^9 platelets/L; hemoglobin ≥11 g/dL; normocellular, no CLL cells, no B-lymphoid nodules in marrow. iwCLL PR decrease of ≥50% in lymph nodes, liver and/or spleen, and CLC from baseline; constitutional symptoms; ≥100 × 10\^9 platelets/L or increase of ≥50% over baseline in platelet count and hemoglobin; presence of CLL cells, or of B-lymphoid nodules, or not done.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=15 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
n=11 Participants
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 Participants
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 Participants
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 Participants
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Objective Response Rate Based on Investigator Assessment: Percentage of Participants With CR/CMR or PR/PMR According to Lugano Criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) Criteria for CLL
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
81.8 percentage of participants
Interval 48.2 to 97.7
|
90.5 percentage of participants
Interval 69.6 to 98.8
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of tafasitamab or parsaclisib and provided at least 1 postdose PK plasma sample. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
Cmax was defined as the maximum observed plasma or serum concentration of tafasitamab.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=53 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Cmax of Tafasitamab When Given in Combination With Parsaclisib
|
324.203 milligrams per liter (mg/L)
Standard Deviation 112.746
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
tmax was defined as the time to the maximum concentration of tafasitamab.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=53 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Tmax of Tafasitamab When Given in Combination With Parsaclisib
|
3.963 hours
Standard Deviation 1.591
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
AUClast was defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=53 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
AUClast of Tafasitamab When Given in Combination With Parsaclisib
|
31379.84 hours x mg/L
Standard Deviation 12369.81
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
AUC0-inf was defined as the area under the plasma concentration-time curve from time zero to infinity (time that the drug is no longer present in the body).
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=51 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
AUC0-inf of Tafasitamab When Given in Combination With Parsaclisib
|
54825.21 hours x mg/L
Standard Deviation 29363.32
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
AUC0-inf was defined as the last measurable plasma drug concentration.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=53 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Clast of Tafasitamab When Given in Combination With Parsaclisib
|
114.386 mg/L
Standard Deviation 56.789
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
t1/2 was defined as the drug's elimination half-life, which is the time it takes for the concentration of a drug in the body to decrease by 50%.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=51 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
t1/2 of Tafasitamab When Given in Combination With Parsaclisib
|
121.702 hours
Standard Deviation 49.506
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
CL was defined as the apparent total body clearance of drug from plasma.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=51 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
CL of Tafasitamab When Given in Combination With Parsaclisib
|
0.021 liter per hour
Standard Deviation 0.015
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusionPopulation: PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.
Vz was defined as the volume of distribution.
Outcome measures
| Measure |
Cohort 1: R/R DLBCL
n=51 Participants
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
VZ of Tafasitamab When Given in Combination With Parsaclisib
|
3.254 liters
Standard Deviation 1.694
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: R/R DLBCL
Serious events: 6 serious events
Other events: 15 other events
Deaths: 9 deaths
Cohort 2: R/R MCL
Serious events: 7 serious events
Other events: 11 other events
Deaths: 7 deaths
Cohort 3: R/R FL
Serious events: 12 serious events
Other events: 21 other events
Deaths: 4 deaths
Cohort 4: R/R MZL
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: R/R CLL/SLL
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: R/R DLBCL
n=15 participants at risk
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
n=11 participants at risk
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 participants at risk
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 participants at risk
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 participants at risk
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
36.4%
4/11 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
COVID-19 pneumonia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
28.6%
6/21 • Number of events 7 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Malaise
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Xerosis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
Other adverse events
| Measure |
Cohort 1: R/R DLBCL
n=15 participants at risk
Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 2: R/R MCL
n=11 participants at risk
Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 3: R/R FL
n=21 participants at risk
Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 4: R/R MZL
n=3 participants at risk
Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
Cohort 5: R/R CLL/SLL
n=4 participants at risk
Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Amylase increased
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
36.4%
4/11 • Number of events 5 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
50.0%
2/4 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
23.8%
5/21 • Number of events 5 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
50.0%
2/4 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Asthenia
|
33.3%
5/15 • Number of events 5 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
27.3%
3/11 • Number of events 6 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
28.6%
6/21 • Number of events 7 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
50.0%
2/4 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
COVID-19
|
20.0%
3/15 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
38.1%
8/21 • Number of events 10 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
50.0%
2/4 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Candida infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
36.4%
4/11 • Number of events 6 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
75.0%
3/4 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
50.0%
2/4 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Number of events 6 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
52.4%
11/21 • Number of events 15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
66.7%
2/3 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
50.0%
2/4 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Nervous system disorders
Dysgraphia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
19.0%
4/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Face oedema
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
General physical health deterioration
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Immune system disorders
Graft versus host disease in liver
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
1/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
23.8%
5/21 • Number of events 5 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
27.3%
3/11 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Lipase increased
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
23.8%
5/21 • Number of events 9 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.7%
7/15 • Number of events 12 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
54.5%
6/11 • Number of events 11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
52.4%
11/21 • Number of events 19 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
100.0%
3/3 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Neutrophil count decreased
|
13.3%
2/15 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Oedema peripheral
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
POEMS syndrome
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Injury, poisoning and procedural complications
Pelvic bone injury
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Platelet count decreased
|
20.0%
3/15 • Number of events 6 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 5 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
27.3%
3/11 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
28.6%
6/21 • Number of events 9 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
19.0%
4/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
6.7%
1/15 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
2/15 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
63.6%
7/11 • Number of events 8 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
18.2%
2/11 • Number of events 4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.5%
2/21 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
14.3%
3/21 • Number of events 3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 2 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/11 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/21 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
33.3%
1/3 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/4 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
|
General disorders
Xerosis
|
0.00%
0/15 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
9.1%
1/11 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
4.8%
1/21 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
0.00%
0/3 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
|
25.0%
1/4 • Number of events 1 • up to 1092 days
Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or 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