Autoimmune Hemolytic Anemia
Conditions
Keywords
autoimmune hemolytic anemia, phosphatidylinositol 3-kinase (PI3K) inhibitor
Brief summary
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.
Interventions
DRUGParsaclisib
Parsaclisib administered orally.
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test. * Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens. * Hemoglobin 7 to 10 g/dL. * No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Willingness to avoid pregnancy or fathering children.
Exclusion criteria
* Pregnant or breastfeeding women. * Concurrent conditions and history of other protocol-specified diseases. * ANC \< 1.5 × 10\^9/L. * Platelet count \< 100 × 10\^9/L. * Severely impaired liver function. * Impaired renal function with estimated creatinine clearance less than 45 mL/min. * Anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies. * Positive serology test results for hepatitis B surface antigen or core antibody, or hepatitis C virus antibody with detectable RNA at screening, consistent with active or chronic infection. * Known HIV infection or positivity on immunoassay. * History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful. * Known hypersensitivity or severe reaction to parsaclisib or its excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12 | Week 6 to Week 12 | A complete response was defined as hemoglobin \>12 grams per deciliter (g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion. |
| Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12 | Week 6 to Week 12 | A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 1638 days | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy, or required changes in the study drug. Anemia and transfusions should not have been reported as AEs unless they represented a clinically meaningful decrease from Baseline in hemoglobin. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | up to 1638 days | A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion. |
| Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | up to 1638 days | Hemoglobin levels were assessed throughout the study. |
| Change From Baseline in Hemoglobin | Baseline; up to 1638 days | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Percentage Change From Baseline in Hemoglobin | Baseline; up to 1638 days | Percentage change from Baseline was calculated as: (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100. |
| Percentage of Participants Requiring Transfusions | Baseline; up to 1638 days | A participant was defined to have required a transfusion if his or her last transfusion was within 7 days of the visit date. |
| Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | up to 1638 days | Normalization was determined by the Investigator based on normal ranges for the clinical reference laboratory. |
| Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | up to 1638 days | Prednisone use was monitored throughout the study. |
| Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Baseline; up to 1638 days | The FACIT-F subscale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in a number of chronic diseases. Participants were asked to respond to 13 statements that people with the illness have said are important on the following scale: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. Participants were asked to indicate the response as it applied to the last 7 days. The total fatigue subscale score ranges from 0 to 52; a higher score indicates more severe impact on daily activities and functioning. |
| Mean Cmax of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | Cmax was defined as the maximum observed concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Mean Tmax of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | tmax was defined as the time to the maximum concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Mean Tlast of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | Tlast was defined as the time of the last measurable concentration (above the quantification limit). Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Mean AUC0-4 of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | AUC0-4 was defined as the area under the concentration-time curve from time = 0 to 4 hours postdose. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Mean AUC0-t of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | AUC0-t was defined as the area under the concentration-time curve from time = 0 to the last measureable concentration at time = t. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Mean Clast of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | Clast was defined as the last measurable concentration (above the quantification limit). Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody | Baseline; Week 12 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Cold Hemagglutinin Levels | Baseline; Week 12 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Baseline; up to 1638 days | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline; up to 1638 days | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in CH50 | Baseline; up to 1638 days | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Complement C3 and Complement C4 | Baseline; up to 1638 days | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Cmin of Parsaclisib | predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8 | Cmin was defined as the minimum observed concentration over the dose interval. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2. |
| Change From Baseline in Reticulocyte Count | Baseline; up to 1638 days | Change from Baseline was calculated as the post-Baseline value minus the Baseline value |
| Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | up to 1638 days | A complete response was defined as hemoglobin \>12 g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion. |
Countries
Austria, France, Italy, United States
Participant flow
Recruitment details
The study was conducted in 25 participants enrolled in 8 sites in Austria, France, Italy, and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Parsaclisib 1 mg QD Participants received oral parsaclisib once daily (QD) for 12 weeks. Participants initially received parsaclisib 1 milligram (mg) QD. At Week 6, participants who continued to require transfusions or did not attain a meaningful clinical response (at least a stabilization of a ≥ 2 grams per deciliter \[g/dL\] increase in hemoglobin from Baseline to Week 6) may have had their dose increased, with sponsor preapproval, to parsaclisib 2.5 mg QD until Week 12. If there were any tolerability issues in individual participants who received 2.5 mg, the dose could have been decreased to 1 mg. Participants who continued to receive clinical benefit after the 12-week Treatment Period could have entered into an Extension Period, during which they, with sponsor approval, continued to receive parsaclisib 1 mg QD or 2.5 mg QD until the drug was available through another clinical study, or was commercially available, or the sponsor stopped the study or the study drug development. Following the last dose of parsaclisib, in either the Treatment Period (for participants not entering the Extension Period) or the Extension Period, participants were eligible for a 12-week (3-month) follow-up period. | 10 |
| Parsaclisib 2.5 mg QD Participants received oral parsaclisib 2.5 mg QD for 12 weeks. If there were any tolerability issues in individual participants, the dose could have been decreased to 1 mg. Participants who continued to receive clinical benefit after the 12-week Treatment Period could have entered into an Extension Period, during which they, with sponsor approval, continued to receive parsaclisib 2.5 mg QD until the drug was available through another clinical study, or was commercially available, or the sponsor stopped the study or the study drug development. Following the last dose of parsaclisib, in either the Treatment Period (for participants not entering the Extension Period) or the Extension Period, participants were eligible for a 12-week (3-month) follow-up period. | 15 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-Week Treatment Period | Adverse Event | 1 | 1 |
| 12-Week Treatment Period | Withdrawal by Subject | 0 | 1 |
| Treatment Extension Period | Adverse Event | 4 | 1 |
| Treatment Extension Period | Death | 0 | 1 |
| Treatment Extension Period | Lack of Efficacy | 1 | 4 |
| Treatment Extension Period | Physician Decision | 1 | 1 |
| Treatment Extension Period | Transitioned to Rollover Study | 1 | 4 |
Baseline characteristics
| Characteristic | Parsaclisib 1 mg QD | Parsaclisib 2.5 mg QD | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 9.63 | 60.3 years STANDARD_DEVIATION 20.74 | 61.6 years STANDARD_DEVIATION 16.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 14 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Hemoglobin | 9.1 grams per deciliter (g/dL) STANDARD_DEVIATION 0.8 | 8.7 grams per deciliter (g/dL) STANDARD_DEVIATION 0.85 | 8.9 grams per deciliter (g/dL) STANDARD_DEVIATION 0.83 |
| Race/Ethnicity, Customized Black/African-American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Captured as Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 1 / 15 |
| other Total, other adverse events | 10 / 10 | 15 / 15 |
| serious Total, serious adverse events | 6 / 10 | 5 / 15 |
Outcome results
Primary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy, or required changes in the study drug. Anemia and transfusions should not have been reported as AEs unless they represented a clinically meaningful decrease from Baseline in hemoglobin. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Time frame: up to 1638 days
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parsaclisib 1 mg QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 10 Participants |
| Parsaclisib 2.5 mg QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 15 Participants |
Primary
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12
A complete response was defined as hemoglobin \>12 grams per deciliter (g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Time frame: Week 6 to Week 12
Population: Full Analysis Set: all participants who enrolled in the study who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12 | 20.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12 | 40.0 percentage of participants |
Primary
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Time frame: Week 6 to Week 12
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12 | 60.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12 | 66.7 percentage of participants |
Secondary
Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 12
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody | IgG at Baseline | 0.0 micrograms per milliliter (µg/mL) | Standard Deviation 0 |
| Parsaclisib 1 mg QD | Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody | IgM at Baseline | 0.0 micrograms per milliliter (µg/mL) | Standard Deviation 0 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody | IgG at Baseline | 5.8 micrograms per milliliter (µg/mL) | Standard Deviation 20.21 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Cardiolipin Immunoglobulin G (IgG) Antibody and Cardiolipin Immunoglobulin M (IgM) Antibody | IgM at Baseline | 1.7 micrograms per milliliter (µg/mL) | Standard Deviation 3.24 |
Secondary
Change From Baseline in CH50
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in CH50 | Baseline in the TP | 84.3 microgram equivalents per Liter (µgEq/L) | Standard Deviation 53.91 |
| Parsaclisib 1 mg QD | Change From Baseline in CH50 | Change from Baseline at Week 12 in the TP | 5.4 microgram equivalents per Liter (µgEq/L) | Standard Deviation 21.66 |
| Parsaclisib 1 mg QD | Change From Baseline in CH50 | Baseline in the EP | 91.5 microgram equivalents per Liter (µgEq/L) | Standard Deviation 52.2 |
| Parsaclisib 1 mg QD | Change From Baseline in CH50 | Change from Baseline at Extension End of Treatment | 27.0 microgram equivalents per Liter (µgEq/L) | — |
| Parsaclisib 2.5 mg QD | Change From Baseline in CH50 | Change from Baseline at Extension End of Treatment | 12.0 microgram equivalents per Liter (µgEq/L) | — |
| Parsaclisib 2.5 mg QD | Change From Baseline in CH50 | Baseline in the TP | 69.5 microgram equivalents per Liter (µgEq/L) | Standard Deviation 53.53 |
| Parsaclisib 2.5 mg QD | Change From Baseline in CH50 | Baseline in the EP | 67.6 microgram equivalents per Liter (µgEq/L) | Standard Deviation 56.61 |
| Parsaclisib 2.5 mg QD | Change From Baseline in CH50 | Change from Baseline at Week 12 in the TP | 17.2 microgram equivalents per Liter (µgEq/L) | Standard Deviation 31.74 |
Secondary
Change From Baseline in Cold Hemagglutinin Levels
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 12
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Cold Hemagglutinin Levels | Baseline | 3200 titer | Standard Deviation 2715.29 |
| Parsaclisib 1 mg QD | Change From Baseline in Cold Hemagglutinin Levels | Change from Baseline at Week 12 | -1760 titer | Standard Deviation 1131.371 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Cold Hemagglutinin Levels | Baseline | 11206.67 titer | Standard Deviation 10309.03 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Cold Hemagglutinin Levels | Change from Baseline at Week 12 | 960 titer | Standard Deviation 1357.645 |
Secondary
Change From Baseline in Complement C3 and Complement C4
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Baseline of the TP | 0.96 grams per Liter (g/L) | Standard Deviation 0.288 |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Baseline of the EP | 0.9400 grams per Liter (g/L) | Standard Deviation 0.1949 |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Change from Baseline at Extension End of Treatment | 0.1000 grams per Liter (g/L) | — |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Baseline of the TP | 0.1736 grams per Liter (g/L) | Standard Deviation 0.0974 |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Change from Baseline at Week 2 of the TP | 0.0410 grams per Liter (g/L) | — |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Change from Baseline at Week 6 of the TP | 0.0330 grams per Liter (g/L) | — |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Change from Baseline at Week 12 of the TP | 0.0136 grams per Liter (g/L) | Standard Deviation 0.0283 |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Baseline of the EP | 0.1628 grams per Liter (g/L) | Standard Deviation 0.0407 |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Change from Baseline at Extension End of Treatment | 0.0170 grams per Liter (g/L) | — |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Change from Baseline at Week 2 of the TP | 0.20 grams per Liter (g/L) | — |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Change from Baseline at Week 6 of the TP | 0.20 grams per Liter (g/L) | — |
| Parsaclisib 1 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Change from Baseline at Week 12 of the TP | 0.04 grams per Liter (g/L) | Standard Deviation 0.098 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Baseline of the TP | 0.91 grams per Liter (g/L) | Standard Deviation 0.183 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Change from Baseline at Extension End of Treatment | 0.1400 grams per Liter (g/L) | — |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Baseline of the EP | 0.1160 grams per Liter (g/L) | Standard Deviation 0.0842 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Baseline of the TP | 0.1242 grams per Liter (g/L) | Standard Deviation 0.1046 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Change from Baseline at Week 12 of the TP | 0.12 grams per Liter (g/L) | Standard Deviation 0.199 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Change from Baseline at Week 12 of the TP | 0.0274 grams per Liter (g/L) | Standard Deviation 0.0366 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C3, Baseline of the EP | 0.9400 grams per Liter (g/L) | Standard Deviation 0.1897 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Complement C3 and Complement C4 | Complement C4, Change from Baseline at Extension End of Treatment | 0.1100 grams per Liter (g/L) | — |
Secondary
Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Baseline of the TP | 0.00 micromoles (µmol)/L | Standard Deviation 0 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 2 of the TP | 0.00 micromoles (µmol)/L | Standard Deviation 0 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 4 of the TP | 0.73 micromoles (µmol)/L | Standard Deviation 1.928 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 6 of the TP | 1.09 micromoles (µmol)/L | Standard Deviation 2.873 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 8 of the TP | 0.00 micromoles (µmol)/L | Standard Deviation 0 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 10 of the TP | 1.55 micromoles (µmol)/L | Standard Deviation 3.579 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 12 of the TP | 0.73 micromoles (µmol)/L | Standard Deviation 1.928 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Follow-up Month 2 of the TP | 0.00 micromoles (µmol)/L | — |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Baseline of the EP | 0.0000 micromoles (µmol)/L | Standard Deviation 0 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Extension End of Treatment | 2.9200 micromoles (µmol)/L | Standard Deviation 5.4906 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Baseline of the TP | 32.7 micromoles (µmol)/L | Standard Deviation 13.29 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 1 of the TP | -6.2 micromoles (µmol)/L | Standard Deviation 7.66 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 2 of the TP | -2.3 micromoles (µmol)/L | Standard Deviation 4.59 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 4 of the TP | -7.6 micromoles (µmol)/L | Standard Deviation 9.63 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 6 of the TP | -11.0 micromoles (µmol)/L | Standard Deviation 14.2 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 8 of the TP | -3.5 micromoles (µmol)/L | Standard Deviation 15.63 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 10 of the TP | -6.5 micromoles (µmol)/L | Standard Deviation 9.95 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 12 of the TP | -2.5 micromoles (µmol)/L | Standard Deviation 13.03 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Baseline of the EP | 35.2500 micromoles (µmol)/L | Standard Deviation 15.7348 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Extension End of Treatment | -34.3610 micromoles (µmol)/L | — |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Baseline of the TP | 34.7 micromoles (µmol)/L | Standard Deviation 19.58 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 1 of the TP | -2.8 micromoles (µmol)/L | Standard Deviation 14.65 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 2 of the TP | 1.7 micromoles (µmol)/L | Standard Deviation 11.94 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 4 of the TP | -2.2 micromoles (µmol)/L | Standard Deviation 16.53 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 6 of the TP | -3.6 micromoles (µmol)/L | Standard Deviation 22.82 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 8 of the TP | -0.9 micromoles (µmol)/L | Standard Deviation 17.24 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 10 of the TP | -2.7 micromoles (µmol)/L | Standard Deviation 17.59 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 12 of the TP | -2.0 micromoles (µmol)/L | Standard Deviation 14.86 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Follow-up Month 2 of the TP | 2.0 micromoles (µmol)/L | — |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Baseline of the EP | 34.7143 micromoles (µmol)/L | Standard Deviation 22.2165 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Extension End of Treatment | -11.7758 micromoles (µmol)/L | Standard Deviation 31.5724 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Baseline of the TP | 14.7 micromoles (µmol)/L | Standard Deviation 2.16 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 1 of the TP | -1.6 micromoles (µmol)/L | Standard Deviation 4.72 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 2 of the TP | -0.5 micromoles (µmol)/L | Standard Deviation 1.97 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 4 of the TP | -1.2 micromoles (µmol)/L | Standard Deviation 4.27 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 6 of the TP | -1.2 micromoles (µmol)/L | Standard Deviation 5.89 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 8 of the TP | 0.0 micromoles (µmol)/L | Standard Deviation 4.24 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 10 of the TP | -0.3 micromoles (µmol)/L | Standard Deviation 2.99 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 12 of the TP | 1.0 micromoles (µmol)/L | Standard Deviation 4.76 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Baseline of the EP | 14.2500 micromoles (µmol)/L | Standard Deviation 2.63 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Extension End of Treatment | -7.1322 micromoles (µmol)/L | Standard Deviation 3.4977 |
| Parsaclisib 1 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 1 of the TP | 0.65 micromoles (µmol)/L | Standard Deviation 1.838 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Baseline of the TP | 0.81 micromoles (µmol)/L | Standard Deviation 3.02 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Extension End of Treatment | -10.6219 micromoles (µmol)/L | Standard Deviation 24.1217 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 1 of the TP | 1.20 micromoles (µmol)/L | Standard Deviation 1.879 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Baseline of the TP | 54.3 micromoles (µmol)/L | Standard Deviation 51.65 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 2 of the TP | 0.90 micromoles (µmol)/L | Standard Deviation 1.64 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 12 of the TP | -12.4 micromoles (µmol)/L | Standard Deviation 28.98 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 4 of the TP | 0.75 micromoles (µmol)/L | Standard Deviation 2.066 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 1 of the TP | -18.3 micromoles (µmol)/L | Standard Deviation 34.92 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 6 of the TP | 2.48 micromoles (µmol)/L | Standard Deviation 5.069 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Baseline of the TP | 22.9 micromoles (µmol)/L | Standard Deviation 39.88 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 8 of the TP | 1.36 micromoles (µmol)/L | Standard Deviation 3.293 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 2 of the TP | -18.7 micromoles (µmol)/L | Standard Deviation 34.44 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 10 of the TP | 1.04 micromoles (µmol)/L | Standard Deviation 2.759 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 8 of the TP | -22.0 micromoles (µmol)/L | Standard Deviation 49.79 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Week 12 of the TP | 1.34 micromoles (µmol)/L | Standard Deviation 2.654 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 4 of the TP | -19.5 micromoles (µmol)/L | Standard Deviation 35.14 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 1 of the TP | -12.1 micromoles (µmol)/L | Standard Deviation 33.14 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Baseline of the EP | 0.0000 micromoles (µmol)/L | Standard Deviation 0 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 6 of the TP | -21.6 micromoles (µmol)/L | Standard Deviation 31.27 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Change from Baseline at Extension End of Treatment | 4.0000 micromoles (µmol)/L | Standard Deviation 5.2386 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Extension End of Treatment | 0.1213 micromoles (µmol)/L | Standard Deviation 6.2545 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Baseline of the TP | 36.1 micromoles (µmol)/L | Standard Deviation 22.77 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 8 of the TP | -22.3 micromoles (µmol)/L | Standard Deviation 41.89 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 1 of the TP | -11.9 micromoles (µmol)/L | Standard Deviation 18.73 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 2 of the TP | -12.0 micromoles (µmol)/L | Standard Deviation 33.84 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 2 of the TP | -11.6 micromoles (µmol)/L | Standard Deviation 17.67 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 10 of the TP | -23.6 micromoles (µmol)/L | Standard Deviation 29.83 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 4 of the TP | -11.1 micromoles (µmol)/L | Standard Deviation 21.63 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 10 of the TP | -13.7 micromoles (µmol)/L | Standard Deviation 32.36 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 6 of the TP | -13.6 micromoles (µmol)/L | Standard Deviation 22.39 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Change from Baseline at Week 12 of the TP | -21.3 micromoles (µmol)/L | Standard Deviation 24.03 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 8 of the TP | -16.8 micromoles (µmol)/L | Standard Deviation 34.58 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 4 of the TP | -14.1 micromoles (µmol)/L | Standard Deviation 38.46 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 10 of the TP | -14.7 micromoles (µmol)/L | Standard Deviation 25.44 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Baseline of the EP | 11.7000 micromoles (µmol)/L | Standard Deviation 2.9458 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Week 12 of the TP | -17.0 micromoles (µmol)/L | Standard Deviation 24.39 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Baseline of the EP | 40.0000 micromoles (µmol)/L | Standard Deviation 27.6586 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Baseline of the EP | 33.4000 micromoles (µmol)/L | Standard Deviation 24.5185 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Change from Baseline at Week 6 of the TP | -14.5 micromoles (µmol)/L | Standard Deviation 35.89 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Change from Baseline at Extension End of Treatment | -0.7057 micromoles (µmol)/L | Standard Deviation 8.3763 |
Secondary
Change From Baseline in Hemoglobin
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Baseline | 9.1 grams per deciliter (g/dL) | Standard Deviation 0.8 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 1 | 0.9 grams per deciliter (g/dL) | Standard Deviation 0.84 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 2 | 0.6 grams per deciliter (g/dL) | Standard Deviation 0.96 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 4 | 0.9 grams per deciliter (g/dL) | Standard Deviation 1.06 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 6 | 1.2 grams per deciliter (g/dL) | Standard Deviation 0.8 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 8 | 1.2 grams per deciliter (g/dL) | Standard Deviation 1.14 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 10 | 1.3 grams per deciliter (g/dL) | Standard Deviation 1.14 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 12 | 1.3 grams per deciliter (g/dL) | Standard Deviation 1.46 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Follow-up Month 1 | 0.1 grams per deciliter (g/dL) | Standard Deviation 1.06 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Follow-up Month 2 | -0.1 grams per deciliter (g/dL) | Standard Deviation 0.28 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Follow-up Month 3 | 0.5 grams per deciliter (g/dL) | Standard Deviation 0.92 |
| Parsaclisib 1 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Extension End of Treatment | 2.8 grams per deciliter (g/dL) | Standard Deviation 2.7 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Follow-up Month 3 | 0.2 grams per deciliter (g/dL) | Standard Deviation 1.63 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Baseline | 8.7 grams per deciliter (g/dL) | Standard Deviation 0.85 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 10 | 2.1 grams per deciliter (g/dL) | Standard Deviation 2.22 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 1 | 1.2 grams per deciliter (g/dL) | Standard Deviation 1.3 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Follow-up Month 2 | -0.2 grams per deciliter (g/dL) | Standard Deviation 0.28 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 2 | 1.5 grams per deciliter (g/dL) | Standard Deviation 1.75 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 12 | 2.5 grams per deciliter (g/dL) | Standard Deviation 2.67 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 4 | 1.6 grams per deciliter (g/dL) | Standard Deviation 1.79 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Extension End of Treatment | 2.6 grams per deciliter (g/dL) | Standard Deviation 2.73 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 6 | 1.7 grams per deciliter (g/dL) | Standard Deviation 1.96 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Follow-up Month 1 | -0.4 grams per deciliter (g/dL) | Standard Deviation 0.72 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Hemoglobin | Change from Baseline at Week 8 | 2.0 grams per deciliter (g/dL) | Standard Deviation 2.07 |
Secondary
Change From Baseline in Lactate Dehydrogenase (LDH)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline of the TP | 328.9 Units (U)/L | Standard Deviation 78.34 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 1 of the TP | 11.8 Units (U)/L | Standard Deviation 70.89 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 2 of the TP | 32.2 Units (U)/L | Standard Deviation 167.98 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 4 of the TP | 65.8 Units (U)/L | Standard Deviation 190.35 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 6 of the TP | 23.9 Units (U)/L | Standard Deviation 133.94 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 8 of the TP | 59.4 Units (U)/L | Standard Deviation 144.2 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 10 of the TP | 36.6 Units (U)/L | Standard Deviation 118.68 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 12 of the TP | 33.8 Units (U)/L | Standard Deviation 117.39 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Follow-up Month 2 of the TP | 44.0 Units (U)/L | — |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline of the EP | 316.9 Units (U)/L | Standard Deviation 86.74 |
| Parsaclisib 1 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Extension End of Treatment | 0.0 Units (U)/L | Standard Deviation 173.26 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline of the TP | 469.0 Units (U)/L | Standard Deviation 208.96 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 8 of the TP | -66.8 Units (U)/L | Standard Deviation 144.36 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 1 of the TP | -85.1 Units (U)/L | Standard Deviation 128.31 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline of the EP | 439.8 Units (U)/L | Standard Deviation 178.39 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 2 of the TP | -82.8 Units (U)/L | Standard Deviation 129.32 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 10 of the TP | -73.5 Units (U)/L | Standard Deviation 153.74 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 4 of the TP | -61.8 Units (U)/L | Standard Deviation 152.8 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Extension End of Treatment | 105.0 Units (U)/L | Standard Deviation 444.64 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 6 of the TP | -71.4 Units (U)/L | Standard Deviation 137.51 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Lactate Dehydrogenase (LDH) | Change from Baseline at Week 12 of the TP | -66.8 Units (U)/L | Standard Deviation 137.28 |
Secondary
Change From Baseline in Reticulocyte Count
Change from Baseline was calculated as the post-Baseline value minus the Baseline value
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 2 of the TP | -17.2571 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 87.7742 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 12 of the TP | -27.1250 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 63.3308 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 6 of the TP | -45.4739 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 61.9611 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Follow-up Month 1 of the TP | 0.0000 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 26.163 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 1 of the TP | -6.8244 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 75.4853 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Follow-up Month 2 of the TP | -18.2000 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 17.6777 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 8 of the TP | -43.0819 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 87.7012 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Follow-up Month 3 of the TP | -31.1500 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 11.243 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 4 of the TP | -24.8375 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 52.5381 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Baseline of the Extension Period (EP) | 233.3086 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 121.4996 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 10 of the TP | -24.3667 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 55.3112 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at End of Treatment during the EP | 184.4096 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 102.9469 |
| Parsaclisib 1 mg QD | Change From Baseline in Reticulocyte Count | Baseline of the Treatment Period (TP) | 240.7460 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 110.0788 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at End of Treatment during the EP | 191.7013 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 131.3629 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Baseline of the Treatment Period (TP) | 268.1429 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 128.3266 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 1 of the TP | -37.9910 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 90.4026 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 2 of the TP | -55.4934 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 88.8296 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 4 of the TP | -67.8155 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 86.6172 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 6 of the TP | -46.3599 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 106.7383 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 8 of the TP | -74.8763 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 97.2582 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 10 of the TP | -50.4759 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 104.4132 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Week 12 of the TP | -80.7566 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 112.2789 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Follow-up Month 1 of the TP | 2.6297 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 16.8763 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Follow-up Month 2 of the TP | -16.4500 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 23.2638 |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Change from Baseline at Follow-up Month 3 of the TP | -131.900 10^9 cells per Liter (10^9 cells/L) | — |
| Parsaclisib 2.5 mg QD | Change From Baseline in Reticulocyte Count | Baseline of the Extension Period (EP) | 243.9526 10^9 cells per Liter (10^9 cells/L) | Standard Deviation 104.442 |
Secondary
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
The FACIT-F subscale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in a number of chronic diseases. Participants were asked to respond to 13 statements that people with the illness have said are important on the following scale: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. Participants were asked to indicate the response as it applied to the last 7 days. The total fatigue subscale score ranges from 0 to 52; a higher score indicates more severe impact on daily activities and functioning.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Baseline | 32.6 scores on a scale | Standard Deviation 12.8 |
| Parsaclisib 1 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Week 6 | 6.7 scores on a scale | Standard Deviation 12.44 |
| Parsaclisib 1 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Week 12 | 6.2 scores on a scale | Standard Deviation 16.08 |
| Parsaclisib 1 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Follow-up Month 1 | 2.0 scores on a scale | Standard Deviation 2.83 |
| Parsaclisib 1 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Follow-up Month 2 | 1.5 scores on a scale | Standard Deviation 7.78 |
| Parsaclisib 1 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Follow-up Month 3 | -2.0 scores on a scale | Standard Deviation 21.21 |
| Parsaclisib 2.5 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Follow-up Month 2 | 7.0 scores on a scale | Standard Deviation 15.56 |
| Parsaclisib 2.5 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Baseline | 30.1 scores on a scale | Standard Deviation 13.88 |
| Parsaclisib 2.5 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Follow-up Month 1 | 2.3 scores on a scale | Standard Deviation 10.69 |
| Parsaclisib 2.5 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Week 6 | 8.2 scores on a scale | Standard Deviation 9.28 |
| Parsaclisib 2.5 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Follow-up Month 3 | 13.0 scores on a scale | Standard Deviation 14.14 |
| Parsaclisib 2.5 mg QD | Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores | Week 12 | 5.4 scores on a scale | Standard Deviation 15.49 |
Secondary
Mean AUC0-4 of Parsaclisib
AUC0-4 was defined as the area under the concentration-time curve from time = 0 to 4 hours postdose. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Mean AUC0-4 of Parsaclisib | Week 2 | 260 hours*nmol/L | Geometric Coefficient of Variation 24 |
| Parsaclisib 1 mg QD | Mean AUC0-4 of Parsaclisib | Week 8 | 287 hours*nmol/L | Geometric Coefficient of Variation 5.73 |
| Parsaclisib 2.5 mg QD | Mean AUC0-4 of Parsaclisib | Week 8 | 631 hours*nmol/L | Geometric Coefficient of Variation 41.9 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean AUC0-4 of Parsaclisib | Week 2 | 542 hours*nmol/L | Geometric Coefficient of Variation 46.7 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean AUC0-4 of Parsaclisib | Week 8 | 524 hours*nmol/L | Geometric Coefficient of Variation 50.8 |
Comparison: Week 2p-value: 0.2676ANOVA
Secondary
Mean AUC0-t of Parsaclisib
AUC0-t was defined as the area under the concentration-time curve from time = 0 to the last measureable concentration at time = t. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Mean AUC0-t of Parsaclisib | Week 2 | 260 hours*nmol/L | Geometric Coefficient of Variation 24 |
| Parsaclisib 1 mg QD | Mean AUC0-t of Parsaclisib | Week 8 | 287 hours*nmol/L | Geometric Coefficient of Variation 5.73 |
| Parsaclisib 2.5 mg QD | Mean AUC0-t of Parsaclisib | Week 8 | 633 hours*nmol/L | Geometric Coefficient of Variation 42.4 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean AUC0-t of Parsaclisib | Week 2 | 553 hours*nmol/L | Geometric Coefficient of Variation 41.3 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean AUC0-t of Parsaclisib | Week 8 | 524 hours*nmol/L | Geometric Coefficient of Variation 50.8 |
Secondary
Mean Clast of Parsaclisib
Clast was defined as the last measurable concentration (above the quantification limit). Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Mean Clast of Parsaclisib | Week 2 | 59.6 nmol/L | Geometric Coefficient of Variation 21.3 |
| Parsaclisib 1 mg QD | Mean Clast of Parsaclisib | Week 8 | 62.4 nmol/L | Geometric Coefficient of Variation 7.31 |
| Parsaclisib 2.5 mg QD | Mean Clast of Parsaclisib | Week 8 | 134 nmol/L | Geometric Coefficient of Variation 54.2 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Clast of Parsaclisib | Week 2 | 128 nmol/L | Geometric Coefficient of Variation 53.3 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Clast of Parsaclisib | Week 8 | 138 nmol/L | Geometric Coefficient of Variation 42.3 |
Secondary
Mean Cmax of Parsaclisib
Cmax was defined as the maximum observed concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: Pharmacokinetic (PK)/Pharmacodynamic (PD) Evaluable Population: all participants who received at least 1 dose of study drug and provided at least 1 postdose blood sample for PK or biomarker assessment. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Mean Cmax of Parsaclisib | Week 2 | 94.9 nanomoles per Liter (nmol/L) | Geometric Coefficient of Variation 33.5 |
| Parsaclisib 1 mg QD | Mean Cmax of Parsaclisib | Week 8 | 107 nanomoles per Liter (nmol/L) | Geometric Coefficient of Variation 17.8 |
| Parsaclisib 2.5 mg QD | Mean Cmax of Parsaclisib | Week 8 | 219 nanomoles per Liter (nmol/L) | Geometric Coefficient of Variation 45.2 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Cmax of Parsaclisib | Week 2 | 191 nanomoles per Liter (nmol/L) | Geometric Coefficient of Variation 56.2 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Cmax of Parsaclisib | Week 8 | 199 nanomoles per Liter (nmol/L) | Geometric Coefficient of Variation 39.7 |
Comparison: Week 2p-value: 0.2815ANOVA
Secondary
Mean Cmin of Parsaclisib
Cmin was defined as the minimum observed concentration over the dose interval. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Mean Cmin of Parsaclisib | Week 2 | 20.0 nmol/L | Geometric Coefficient of Variation 88.7 |
| Parsaclisib 1 mg QD | Mean Cmin of Parsaclisib | Week 8 | 14.2 nmol/L | Geometric Coefficient of Variation 80.9 |
| Parsaclisib 2.5 mg QD | Mean Cmin of Parsaclisib | Week 8 | 39.4 nmol/L | Geometric Coefficient of Variation 26.1 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Cmin of Parsaclisib | Week 2 | 32.3 nmol/L | Geometric Coefficient of Variation 55.4 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Cmin of Parsaclisib | Week 8 | 25.5 nmol/L | Geometric Coefficient of Variation 91.4 |
Comparison: Week 2p-value: 0.1267ANOVA
Secondary
Mean Tlast of Parsaclisib
Tlast was defined as the time of the last measurable concentration (above the quantification limit). Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Mean Tlast of Parsaclisib | Week 2 | 3.85 hours | Geometric Coefficient of Variation 4.77 |
| Parsaclisib 1 mg QD | Mean Tlast of Parsaclisib | Week 8 | 3.83 hours | Geometric Coefficient of Variation 5.84 |
| Parsaclisib 2.5 mg QD | Mean Tlast of Parsaclisib | Week 8 | 3.92 hours | Geometric Coefficient of Variation 3.71 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Tlast of Parsaclisib | Week 2 | 3.98 hours | Geometric Coefficient of Variation 9.67 |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Tlast of Parsaclisib | Week 8 | 3.84 hours | Geometric Coefficient of Variation 6.56 |
Secondary
Mean Tmax of Parsaclisib
tmax was defined as the time to the maximum concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Time frame: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8
Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Mean Tmax of Parsaclisib | Week 2 | 1.00 hours |
| Parsaclisib 1 mg QD | Mean Tmax of Parsaclisib | Week 8 | 1.00 hours |
| Parsaclisib 2.5 mg QD | Mean Tmax of Parsaclisib | Week 8 | 1.04 hours |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Tmax of Parsaclisib | Week 2 | 1.00 hours |
| Cohort 2: Parsaclisib 2.5 mg QD | Mean Tmax of Parsaclisib | Week 8 | 1.02 hours |
Comparison: Week 2p-value: 0.2921Kruskal-Wallis
Secondary
Percentage Change From Baseline in Hemoglobin
Percentage change from Baseline was calculated as: (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 6 | 13.3 percent change | Standard Deviation 8.35 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 12 | 13.9 percent change | Standard Deviation 15.72 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 4 | 9.9 percent change | Standard Deviation 10.83 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Follow-up Month 1 | 0.0 percent change | Standard Deviation 12.26 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 8 | 12.7 percent change | Standard Deviation 12.16 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Follow-up Month 2 | -1.0 percent change | Standard Deviation 3.18 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 2 | 6.0 percent change | Standard Deviation 10.26 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Follow-up Month 3 | 5.7 percent change | Standard Deviation 11.14 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 10 | 14.1 percent change | Standard Deviation 11.54 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Extension End of Treatment | 31.6 percent change | Standard Deviation 33.86 |
| Parsaclisib 1 mg QD | Percentage Change From Baseline in Hemoglobin | Week 1 | 10.1 percent change | Standard Deviation 9.23 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Extension End of Treatment | 30.9 percent change | Standard Deviation 33.52 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 1 | 14.4 percent change | Standard Deviation 16.31 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 2 | 18.5 percent change | Standard Deviation 20.71 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 4 | 19.2 percent change | Standard Deviation 20.65 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 6 | 19.5 percent change | Standard Deviation 22.35 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 8 | 23.4 percent change | Standard Deviation 24.57 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 10 | 25.1 percent change | Standard Deviation 26.3 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Week 12 | 30.2 percent change | Standard Deviation 33.95 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Follow-up Month 1 | -4.1 percent change | Standard Deviation 7.92 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Follow-up Month 2 | -2.0 percent change | Standard Deviation 2.89 |
| Parsaclisib 2.5 mg QD | Percentage Change From Baseline in Hemoglobin | Follow-up Month 3 | 2.0 percent change | Standard Deviation 17.32 |
Secondary
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Hemoglobin levels were assessed throughout the study.
Time frame: up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 6 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 12 | 33.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 4 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 8 | 33.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 2 | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 10 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Extension End of Treatment | 66.7 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Extension End of Treatment | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 1 | 26.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 2 | 46.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 4 | 42.9 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 6 | 35.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 8 | 38.5 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 10 | 46.2 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Week 12 | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline | Follow-up Month 3 | 0.0 percentage of participants |
Secondary
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
A complete response was defined as hemoglobin \>12 g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Time frame: up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 6 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 12 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 4 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 8 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 2 | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 10 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Extension End of Treatment | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Extension End of Treatment | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 1 | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 2 | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 4 | 21.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 6 | 28.6 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 8 | 23.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 10 | 23.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Week 12 | 42.9 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Complete Response During Post-Baseline Visits | Follow-up Month 3 | 0.0 percentage of participants |
Secondary
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Time frame: up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 1 | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 12 | 55.6 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 4 | 44.4 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Follow-up Month 1 | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 10 | 55.6 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 6 | 44.4 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 2 | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Extension End of Treatment | 83.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 8 | 55.6 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Extension End of Treatment | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 1 | 53.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 2 | 66.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 4 | 64.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 6 | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 10 | 61.5 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 12 | 64.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Follow-up Month 3 | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Attaining a Partial Response During Post-Baseline Visits | Week 8 | 61.5 percentage of participants |
Secondary
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Prednisone use was monitored throughout the study.
Time frame: up to 1638 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 1, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 1, decreased | 20.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 2, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 2, decreased | 20.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 4, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 4, decreased | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 6, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 6, decreased | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 8, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 8, decreased | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 10, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 10, decreased | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 12, increased | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 12, decreased | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Extension End of Treatment, increased | 10.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Extension End of Treatment, decreased | 10.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Extension End of Treatment, decreased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 1, increased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 8, increased | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 1, decreased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 12, increased | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 2, increased | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 8, decreased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 2, decreased | 13.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Extension End of Treatment, increased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 4, increased | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 10, increased | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 4, decreased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 12, decreased | 20.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 6, increased | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 10, decreased | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease) | Week 6, decreased | 6.7 percentage of participants |
Secondary
Percentage of Participants Requiring Transfusions
A participant was defined to have required a transfusion if his or her last transfusion was within 7 days of the visit date.
Time frame: Baseline; up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 4 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 12 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 6 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 8 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Extension End of Treatment | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Requiring Transfusions | Week 10 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Extension End of Treatment | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 1 | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 6 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 8 | 15.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 10 | 7.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 12 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Requiring Transfusions | Week 4 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Normalization was determined by the Investigator based on normal ranges for the clinical reference laboratory.
Time frame: up to 1638 days
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 1 | 30.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 6 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 8 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 10 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 12 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 4 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 6 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 8 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 10 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 12 | 11.1 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 1 | 12.5 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 4 | 14.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 6 | 14.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 8 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 10 | 12.5 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 12 | 14.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 1 | 12.5 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 2 | 11.1 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 4 | 12.5 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 6 | 14.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 8 | 25.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 10 | 33.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 12 | 25.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 1 | 20.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 2 | 28.6 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 4 | 25.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 6 | 22.2 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 8 | 25.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 10 | 33.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 12 | 37.5 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Follow-up Month 1 | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Follow-up Month 2 | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Follow-up Month 3 | 50.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 2 | 20.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 4 | 33.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 6 | 33.3 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 8 | 44.4 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 10 | 44.4 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 12 | 44.4 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Follow-up Month 2 | 100.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 1 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 2 | 12.5 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 4 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 6 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 8 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 10 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 12 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 2 | 0.0 percentage of participants |
| Parsaclisib 1 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 4 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 1 | 12.5 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 6 | 14.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 12 | 28.6 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 4 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 8 | 9.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 6 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 1 | 40.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 8 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 10 | 9.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 10 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 6 | 25.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Indirect bilirubin, Week 12 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 12 | 15.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 1 | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 2 | 40.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 2 | 6.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 1 | 25.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 4 | 14.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 1 | 14.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 6 | 21.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 4 | 42.9 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 8 | 15.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 2 | 20.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 10 | 15.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 10 | 14.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Week 12 | 35.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 4 | 28.6 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 6 | 42.9 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 6 | 28.6 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Hemoglobin, Follow-up Month 3 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 2 | 22.2 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 1 | 22.2 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 8 | 25.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 2 | 18.2 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 8 | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 4 | 15.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 10 | 25.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 6 | 23.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 8 | 20.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 8 | 11.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Week 12 | 23.1 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 10 | 14.3 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 10 | 36.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Haptoglobin, Week 12 | 25.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Follow-up Month 1 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Direct bilirubin, Week 4 | 12.5 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 1 | 10.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Follow-up Month 2 | 0.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 2 | 16.7 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Total bilirubin, Week 12 | 50.0 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | LDH, Week 4 | 21.4 percentage of participants |
| Parsaclisib 2.5 mg QD | Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin | Reticulocytes, Follow-up Month 3 | 0.0 percentage of participants |