Trial Outcomes & Findings for A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (NCT NCT03538041)
NCT ID: NCT03538041
Last Updated: 2025-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Week 6 to Week 12
Results posted on
2025-07-11
Participant Flow
The study was conducted in 25 participants enrolled in 8 sites in Austria, France, Italy, and the United States.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
12-Week Treatment Period
STARTED
|
10
|
15
|
|
12-Week Treatment Period
COMPLETED
|
9
|
13
|
|
12-Week Treatment Period
NOT COMPLETED
|
1
|
2
|
|
Treatment Extension Period
STARTED
|
7
|
11
|
|
Treatment Extension Period
COMPLETED
|
0
|
0
|
|
Treatment Extension Period
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
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
Physician Decision
|
1
|
1
|
|
Treatment Extension Period
Lack of Efficacy
|
1
|
4
|
|
Treatment Extension Period
Transitioned to Rollover Study
|
1
|
4
|
|
Treatment Extension Period
Death
|
0
|
1
|
Baseline Characteristics
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
Baseline characteristics by cohort
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 20.74 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 16.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other"
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hemoglobin
|
9.1 grams per deciliter (g/dL)
STANDARD_DEVIATION 0.80 • n=5 Participants
|
8.7 grams per deciliter (g/dL)
STANDARD_DEVIATION 0.85 • n=7 Participants
|
8.9 grams per deciliter (g/dL)
STANDARD_DEVIATION 0.83 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6 to Week 12Population: Full Analysis Set: all participants who enrolled in the study who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12
|
20.0 percentage of participants
|
40.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Week 6 to Week 12Population: Full Analysis Set
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12
|
60.0 percentage of participants
|
66.7 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: up to 1638 daysPopulation: Full Analysis Set
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
10 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 1
|
0.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 2
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 4
|
22.2 percentage of participants
|
21.4 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 6
|
22.2 percentage of participants
|
28.6 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 8
|
22.2 percentage of participants
|
23.1 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 10
|
22.2 percentage of participants
|
23.1 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Week 12
|
22.2 percentage of participants
|
42.9 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Follow-up Month 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Follow-up Month 2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Follow-up Month 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits
Extension End of Treatment
|
50.0 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 1
|
50.0 percentage of participants
|
53.3 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 2
|
50.0 percentage of participants
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 4
|
44.4 percentage of participants
|
64.3 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 6
|
44.4 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 8
|
55.6 percentage of participants
|
61.5 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 10
|
55.6 percentage of participants
|
61.5 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Week 12
|
55.6 percentage of participants
|
64.3 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Follow-up Month 1
|
50.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Follow-up Month 2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Follow-up Month 3
|
0.0 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a Partial Response During Post-Baseline Visits
Extension End of Treatment
|
83.3 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Hemoglobin levels were assessed throughout the study.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 4
|
22.2 percentage of participants
|
42.9 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 1
|
0.0 percentage of participants
|
26.7 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 2
|
10.0 percentage of participants
|
46.7 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 6
|
22.2 percentage of participants
|
35.7 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 8
|
33.3 percentage of participants
|
38.5 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 10
|
22.2 percentage of participants
|
46.2 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Week 12
|
33.3 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Follow-up Month 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Follow-up Month 2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Follow-up Month 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline
Extension End of Treatment
|
66.7 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin
Baseline
|
9.1 grams per deciliter (g/dL)
Standard Deviation 0.80
|
8.7 grams per deciliter (g/dL)
Standard Deviation 0.85
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 1
|
0.9 grams per deciliter (g/dL)
Standard Deviation 0.84
|
1.2 grams per deciliter (g/dL)
Standard Deviation 1.30
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 2
|
0.6 grams per deciliter (g/dL)
Standard Deviation 0.96
|
1.5 grams per deciliter (g/dL)
Standard Deviation 1.75
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 4
|
0.9 grams per deciliter (g/dL)
Standard Deviation 1.06
|
1.6 grams per deciliter (g/dL)
Standard Deviation 1.79
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 6
|
1.2 grams per deciliter (g/dL)
Standard Deviation 0.80
|
1.7 grams per deciliter (g/dL)
Standard Deviation 1.96
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 8
|
1.2 grams per deciliter (g/dL)
Standard Deviation 1.14
|
2.0 grams per deciliter (g/dL)
Standard Deviation 2.07
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 10
|
1.3 grams per deciliter (g/dL)
Standard Deviation 1.14
|
2.1 grams per deciliter (g/dL)
Standard Deviation 2.22
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Week 12
|
1.3 grams per deciliter (g/dL)
Standard Deviation 1.46
|
2.5 grams per deciliter (g/dL)
Standard Deviation 2.67
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Follow-up Month 1
|
0.1 grams per deciliter (g/dL)
Standard Deviation 1.06
|
-0.4 grams per deciliter (g/dL)
Standard Deviation 0.72
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Follow-up Month 2
|
-0.1 grams per deciliter (g/dL)
Standard Deviation 0.28
|
-0.2 grams per deciliter (g/dL)
Standard Deviation 0.28
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Follow-up Month 3
|
0.5 grams per deciliter (g/dL)
Standard Deviation 0.92
|
0.2 grams per deciliter (g/dL)
Standard Deviation 1.63
|
—
|
|
Change From Baseline in Hemoglobin
Change from Baseline at Extension End of Treatment
|
2.8 grams per deciliter (g/dL)
Standard Deviation 2.70
|
2.6 grams per deciliter (g/dL)
Standard Deviation 2.73
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Percentage change from Baseline was calculated as: (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage Change From Baseline in Hemoglobin
Week 12
|
13.9 percent change
Standard Deviation 15.72
|
30.2 percent change
Standard Deviation 33.95
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Follow-up Month 1
|
0.0 percent change
Standard Deviation 12.26
|
-4.1 percent change
Standard Deviation 7.92
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Follow-up Month 2
|
-1.0 percent change
Standard Deviation 3.18
|
-2.0 percent change
Standard Deviation 2.89
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Week 1
|
10.1 percent change
Standard Deviation 9.23
|
14.4 percent change
Standard Deviation 16.31
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Week 2
|
6.0 percent change
Standard Deviation 10.26
|
18.5 percent change
Standard Deviation 20.71
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Week 4
|
9.9 percent change
Standard Deviation 10.83
|
19.2 percent change
Standard Deviation 20.65
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Week 6
|
13.3 percent change
Standard Deviation 8.35
|
19.5 percent change
Standard Deviation 22.35
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Week 8
|
12.7 percent change
Standard Deviation 12.16
|
23.4 percent change
Standard Deviation 24.57
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Week 10
|
14.1 percent change
Standard Deviation 11.54
|
25.1 percent change
Standard Deviation 26.30
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Follow-up Month 3
|
5.7 percent change
Standard Deviation 11.14
|
2.0 percent change
Standard Deviation 17.32
|
—
|
|
Percentage Change From Baseline in Hemoglobin
Extension End of Treatment
|
31.6 percent change
Standard Deviation 33.86
|
30.9 percent change
Standard Deviation 33.52
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
A participant was defined to have required a transfusion if his or her last transfusion was within 7 days of the visit date.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Requiring Transfusions
Week 12
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Week 1
|
0.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Week 2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Week 4
|
22.2 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Week 6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Week 8
|
0.0 percentage of participants
|
15.4 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Week 10
|
0.0 percentage of participants
|
7.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Follow-up Month 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Follow-up Month 2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Follow-up Month 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring Transfusions
Extension End of Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Normalization was determined by the Investigator based on normal ranges for the clinical reference laboratory.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
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
|
6.7 percentage of participants
|
—
|
|
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
|
6.7 percentage of participants
|
—
|
|
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
|
14.3 percentage of participants
|
—
|
|
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
|
21.4 percentage of participants
|
—
|
|
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
|
15.4 percentage of participants
|
—
|
|
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
|
15.4 percentage of participants
|
—
|
|
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
|
35.7 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
22.2 percentage of participants
|
—
|
|
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
|
18.2 percentage of participants
|
—
|
|
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
|
15.4 percentage of participants
|
—
|
|
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
|
23.1 percentage of participants
|
—
|
|
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
|
11.1 percentage of participants
|
—
|
|
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
|
14.3 percentage of participants
|
—
|
|
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
|
25.0 percentage of participants
|
—
|
|
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
|
—
|
—
|
|
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
|
10.0 percentage of participants
|
—
|
|
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
|
16.7 percentage of participants
|
—
|
|
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
|
21.4 percentage of participants
|
—
|
|
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
|
14.3 percentage of participants
|
—
|
|
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
|
9.1 percentage of participants
|
—
|
|
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
|
9.1 percentage of participants
|
—
|
|
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
|
15.4 percentage of participants
|
—
|
|
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
|
—
|
—
|
|
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
|
14.3 percentage of participants
|
—
|
|
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
|
20.0 percentage of participants
|
—
|
|
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
|
28.6 percentage of participants
|
—
|
|
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
|
28.6 percentage of participants
|
—
|
|
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
|
25.0 percentage of participants
|
—
|
|
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
|
25.0 percentage of participants
|
—
|
|
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
|
23.1 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
40.0 percentage of participants
|
—
|
|
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
|
40.0 percentage of participants
|
—
|
|
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
|
42.9 percentage of participants
|
—
|
|
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
|
42.9 percentage of participants
|
—
|
|
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
|
50.0 percentage of participants
|
—
|
|
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
|
36.4 percentage of participants
|
—
|
|
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
|
50.0 percentage of participants
|
—
|
|
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
|
—
|
—
|
|
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
|
25.0 percentage of participants
|
—
|
|
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
|
22.2 percentage of participants
|
—
|
|
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
|
12.5 percentage of participants
|
—
|
|
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
|
25.0 percentage of participants
|
—
|
|
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
|
20.0 percentage of participants
|
—
|
|
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
|
14.3 percentage of participants
|
—
|
|
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
|
28.6 percentage of participants
|
—
|
|
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
|
12.5 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
|
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
|
0.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: up to 1638 daysPopulation: Full Analysis Set
Prednisone use was monitored throughout the study.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 10, decreased
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Extension End of Treatment, decreased
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 1, increased
|
0.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 1, decreased
|
20.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 2, increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 2, decreased
|
20.0 percentage of participants
|
13.3 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 4, increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 4, decreased
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 6, increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 6, decreased
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 8, increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 8, decreased
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 10, increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 12, increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Week 12, decreased
|
10.0 percentage of participants
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)
Extension End of Treatment, increased
|
10.0 percentage of participants
|
6.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
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 12.80
|
30.1 scores on a scale
Standard Deviation 13.88
|
—
|
|
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
|
8.2 scores on a scale
Standard Deviation 9.28
|
—
|
|
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
|
5.4 scores on a scale
Standard Deviation 15.49
|
—
|
|
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
|
2.3 scores on a scale
Standard Deviation 10.69
|
—
|
|
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
|
7.0 scores on a scale
Standard Deviation 15.56
|
—
|
|
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
|
13.0 scores on a scale
Standard Deviation 14.14
|
—
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: 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.
Cmax was defined as the maximum observed concentration. Participants in Cohort 1 were not eligible to receive parsaclisib 2.5 mg at Week 2.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean Cmax of Parsaclisib
Week 2
|
94.9 nanomoles per Liter (nmol/L)
Geometric Coefficient of Variation 33.5
|
—
|
191 nanomoles per Liter (nmol/L)
Geometric Coefficient of Variation 56.2
|
|
Mean Cmax of Parsaclisib
Week 8
|
107 nanomoles per Liter (nmol/L)
Geometric Coefficient of Variation 17.8
|
219 nanomoles per Liter (nmol/L)
Geometric Coefficient of Variation 45.2
|
199 nanomoles per Liter (nmol/L)
Geometric Coefficient of Variation 39.7
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean Tmax of Parsaclisib
Week 2
|
1.00 hours
Interval 0.0 to 2.07
|
—
|
1.00 hours
Interval 0.0 to 3.33
|
|
Mean Tmax of Parsaclisib
Week 8
|
1.00 hours
Interval 1.0 to 1.05
|
1.04 hours
Interval 0.917 to 2.0
|
1.02 hours
Interval 0.833 to 4.0
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean Cmin of Parsaclisib
Week 2
|
20.0 nmol/L
Geometric Coefficient of Variation 88.7
|
—
|
32.3 nmol/L
Geometric Coefficient of Variation 55.4
|
|
Mean Cmin of Parsaclisib
Week 8
|
14.2 nmol/L
Geometric Coefficient of Variation 80.9
|
39.4 nmol/L
Geometric Coefficient of Variation 26.1
|
25.5 nmol/L
Geometric Coefficient of Variation 91.4
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean AUC0-4 of Parsaclisib
Week 2
|
260 hours*nmol/L
Geometric Coefficient of Variation 24.0
|
—
|
542 hours*nmol/L
Geometric Coefficient of Variation 46.7
|
|
Mean AUC0-4 of Parsaclisib
Week 8
|
287 hours*nmol/L
Geometric Coefficient of Variation 5.73
|
631 hours*nmol/L
Geometric Coefficient of Variation 41.9
|
524 hours*nmol/L
Geometric Coefficient of Variation 50.8
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean AUC0-t of Parsaclisib
Week 2
|
260 hours*nmol/L
Geometric Coefficient of Variation 24.0
|
—
|
553 hours*nmol/L
Geometric Coefficient of Variation 41.3
|
|
Mean AUC0-t of Parsaclisib
Week 8
|
287 hours*nmol/L
Geometric Coefficient of Variation 5.73
|
633 hours*nmol/L
Geometric Coefficient of Variation 42.4
|
524 hours*nmol/L
Geometric Coefficient of Variation 50.8
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean Clast of Parsaclisib
Week 2
|
59.6 nmol/L
Geometric Coefficient of Variation 21.3
|
—
|
128 nmol/L
Geometric Coefficient of Variation 53.3
|
|
Mean Clast of Parsaclisib
Week 8
|
62.4 nmol/L
Geometric Coefficient of Variation 7.31
|
134 nmol/L
Geometric Coefficient of Variation 54.2
|
138 nmol/L
Geometric Coefficient of Variation 42.3
|
SECONDARY outcome
Timeframe: predose at Weeks 1 and 12; predose and 1, 2, and 4 hours postdose at Weeks 2 and 8Population: PK/PD Evaluable Population. Only participants with available data were analyzed.
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.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
n=15 Participants
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Mean Tlast of Parsaclisib
Week 2
|
3.85 hours
Geometric Coefficient of Variation 4.77
|
—
|
3.98 hours
Geometric Coefficient of Variation 9.67
|
|
Mean Tlast of Parsaclisib
Week 8
|
3.83 hours
Geometric Coefficient of Variation 5.84
|
3.92 hours
Geometric Coefficient of Variation 3.71
|
3.84 hours
Geometric Coefficient of Variation 6.56
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
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
|
268.1429 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 128.3266
|
—
|
|
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
|
-37.9910 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 90.4026
|
—
|
|
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
|
-55.4934 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 88.8296
|
—
|
|
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
|
-67.8155 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 86.6172
|
—
|
|
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
|
-46.3599 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 106.7383
|
—
|
|
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
|
-74.8763 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 97.2582
|
—
|
|
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
|
-50.4759 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 104.4132
|
—
|
|
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
|
-80.7566 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 112.2789
|
—
|
|
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 26.1630
|
2.6297 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 16.8763
|
—
|
|
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
|
-16.4500 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 23.2638
|
—
|
|
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 11.2430
|
-131.900 10^9 cells per Liter (10^9 cells/L)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
|
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
|
243.9526 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 104.4420
|
—
|
|
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
|
191.7013 10^9 cells per Liter (10^9 cells/L)
Standard Deviation 131.3629
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=9 Participants
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.
|
Parsaclisib 2.5 mg QD
n=12 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
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 0.00
|
5.8 micrograms per milliliter (µg/mL)
Standard Deviation 20.21
|
—
|
|
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 0.00
|
1.7 micrograms per milliliter (µg/mL)
Standard Deviation 3.24
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=2 Participants
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.
|
Parsaclisib 2.5 mg QD
n=6 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Cold Hemagglutinin Levels
Baseline
|
3200 titer
Standard Deviation 2715.29
|
11206.67 titer
Standard Deviation 10309.03
|
—
|
|
Change From Baseline in Cold Hemagglutinin Levels
Change from Baseline at Week 12
|
-1760 titer
Standard Deviation 1131.371
|
960 titer
Standard Deviation 1357.645
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
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 0.000
|
1.36 micromoles (µmol)/L
Standard Deviation 3.293
|
—
|
|
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
|
1.04 micromoles (µmol)/L
Standard Deviation 2.759
|
—
|
|
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
|
1.34 micromoles (µmol)/L
Standard Deviation 2.654
|
—
|
|
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
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Haptoglobin, Baseline of the EP
|
0.0000 micromoles (µmol)/L
Standard Deviation 0.0000
|
0.0000 micromoles (µmol)/L
Standard Deviation 0.0000
|
—
|
|
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
|
4.0000 micromoles (µmol)/L
Standard Deviation 5.2386
|
—
|
|
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
|
-14.1 micromoles (µmol)/L
Standard Deviation 38.46
|
—
|
|
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
|
-14.5 micromoles (µmol)/L
Standard Deviation 35.89
|
—
|
|
Change From Baseline in Haptoglobin, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin
Haptoglobin, Baseline of the TP
|
0.00 micromoles (µmol)/L
Standard Deviation 0.000
|
0.81 micromoles (µmol)/L
Standard Deviation 3.020
|
—
|
|
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
|
1.20 micromoles (µmol)/L
Standard Deviation 1.879
|
—
|
|
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 0.000
|
0.90 micromoles (µmol)/L
Standard Deviation 1.640
|
—
|
|
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
|
0.75 micromoles (µmol)/L
Standard Deviation 2.066
|
—
|
|
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
|
2.48 micromoles (µmol)/L
Standard Deviation 5.069
|
—
|
|
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
|
36.1 micromoles (µmol)/L
Standard Deviation 22.77
|
—
|
|
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
|
-11.9 micromoles (µmol)/L
Standard Deviation 18.73
|
—
|
|
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
|
-11.6 micromoles (µmol)/L
Standard Deviation 17.67
|
—
|
|
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
|
-11.1 micromoles (µmol)/L
Standard Deviation 21.63
|
—
|
|
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 14.20
|
-13.6 micromoles (µmol)/L
Standard Deviation 22.39
|
—
|
|
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
|
-16.8 micromoles (µmol)/L
Standard Deviation 34.58
|
—
|
|
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
|
-14.7 micromoles (µmol)/L
Standard Deviation 25.44
|
—
|
|
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
|
-17.0 micromoles (µmol)/L
Standard Deviation 24.39
|
—
|
|
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
|
33.4000 micromoles (µmol)/L
Standard Deviation 24.5185
|
—
|
|
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
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
-0.7057 micromoles (µmol)/L
Standard Deviation 8.3763
|
—
|
|
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
|
54.3 micromoles (µmol)/L
Standard Deviation 51.65
|
—
|
|
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
|
-18.3 micromoles (µmol)/L
Standard Deviation 34.92
|
—
|
|
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
|
-18.7 micromoles (µmol)/L
Standard Deviation 34.44
|
—
|
|
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
|
-19.5 micromoles (µmol)/L
Standard Deviation 35.14
|
—
|
|
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
|
-21.6 micromoles (µmol)/L
Standard Deviation 31.27
|
—
|
|
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
|
-22.3 micromoles (µmol)/L
Standard Deviation 41.89
|
—
|
|
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
|
-23.6 micromoles (µmol)/L
Standard Deviation 29.83
|
—
|
|
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
|
-21.3 micromoles (µmol)/L
Standard Deviation 24.03
|
—
|
|
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
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
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
|
40.0000 micromoles (µmol)/L
Standard Deviation 27.6586
|
—
|
|
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
|
-10.6219 micromoles (µmol)/L
Standard Deviation 24.1217
|
—
|
|
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
|
22.9 micromoles (µmol)/L
Standard Deviation 39.88
|
—
|
|
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
|
-12.1 micromoles (µmol)/L
Standard Deviation 33.14
|
—
|
|
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
|
-12.0 micromoles (µmol)/L
Standard Deviation 33.84
|
—
|
|
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
|
-22.0 micromoles (µmol)/L
Standard Deviation 49.79
|
—
|
|
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
|
-13.7 micromoles (µmol)/L
Standard Deviation 32.36
|
—
|
|
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
|
-12.4 micromoles (µmol)/L
Standard Deviation 28.98
|
—
|
|
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 2.6300
|
11.7000 micromoles (µmol)/L
Standard Deviation 2.9458
|
—
|
|
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
|
0.1213 micromoles (µmol)/L
Standard Deviation 6.2545
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Lactate Dehydrogenase (LDH)
Baseline of the TP
|
328.9 Units (U)/L
Standard Deviation 78.34
|
469.0 Units (U)/L
Standard Deviation 208.96
|
—
|
|
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
|
-85.1 Units (U)/L
Standard Deviation 128.31
|
—
|
|
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
|
-82.8 Units (U)/L
Standard Deviation 129.32
|
—
|
|
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
|
-61.8 Units (U)/L
Standard Deviation 152.80
|
—
|
|
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
|
-71.4 Units (U)/L
Standard Deviation 137.51
|
—
|
|
Change From Baseline in Lactate Dehydrogenase (LDH)
Change from Baseline at Week 8 of the TP
|
59.4 Units (U)/L
Standard Deviation 144.20
|
-66.8 Units (U)/L
Standard Deviation 144.36
|
—
|
|
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
|
-73.5 Units (U)/L
Standard Deviation 153.74
|
—
|
|
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
|
-66.8 Units (U)/L
Standard Deviation 137.28
|
—
|
|
Change From Baseline in Lactate Dehydrogenase (LDH)
Change from Baseline at Follow-up Month 2 of the TP
|
44.0 Units (U)/L
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
Change From Baseline in Lactate Dehydrogenase (LDH)
Baseline of the EP
|
316.9 Units (U)/L
Standard Deviation 86.74
|
439.8 Units (U)/L
Standard Deviation 178.39
|
—
|
|
Change From Baseline in Lactate Dehydrogenase (LDH)
Change from Baseline at Extension End of Treatment
|
0.0 Units (U)/L
Standard Deviation 173.26
|
105.0 Units (U)/L
Standard Deviation 444.64
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in CH50
Baseline in the EP
|
91.5 microgram equivalents per Liter (µgEq/L)
Standard Deviation 52.20
|
67.6 microgram equivalents per Liter (µgEq/L)
Standard Deviation 56.61
|
—
|
|
Change From Baseline in CH50
Baseline in the TP
|
84.3 microgram equivalents per Liter (µgEq/L)
Standard Deviation 53.91
|
69.5 microgram equivalents per Liter (µgEq/L)
Standard Deviation 53.53
|
—
|
|
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
|
17.2 microgram equivalents per Liter (µgEq/L)
Standard Deviation 31.74
|
—
|
|
Change From Baseline in CH50
Change from Baseline at Extension End of Treatment
|
27.0 microgram equivalents per Liter (µgEq/L)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
12.0 microgram equivalents per Liter (µgEq/L)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline; up to 1638 daysPopulation: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Parsaclisib 1 mg QD
n=10 Participants
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.
|
Parsaclisib 2.5 mg QD
n=15 Participants
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.
|
Cohort 2: Parsaclisib 2.5 mg QD
Participants received oral parsaclisib 2.5 mg QD for 12 weeks.
|
|---|---|---|---|
|
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
|
0.91 grams per Liter (g/L)
Standard Deviation 0.183
|
—
|
|
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
|
0.1242 grams per Liter (g/L)
Standard Deviation 0.1046
|
—
|
|
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)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
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)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
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
|
0.12 grams per Liter (g/L)
Standard Deviation 0.199
|
—
|
|
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
|
0.9400 grams per Liter (g/L)
Standard Deviation 0.1897
|
—
|
|
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)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
0.1400 grams per Liter (g/L)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
|
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)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
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)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
—
|
|
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
|
0.0274 grams per Liter (g/L)
Standard Deviation 0.0366
|
—
|
|
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
|
0.1160 grams per Liter (g/L)
Standard Deviation 0.0842
|
—
|
|
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)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
0.1100 grams per Liter (g/L)
Standard Deviation NA
Standard deviation cannot be calculated for a single participant.
|
—
|
Adverse Events
Parsaclisib 1 mg QD
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Parsaclisib 2.5 mg QD
Serious events: 5 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Parsaclisib 1 mg QD
n=10 participants at risk
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.
|
Parsaclisib 2.5 mg QD
n=15 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Amoebic dysentery
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Vascular disorders
Aortic thrombosis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
COVID-19 pneumonia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Campylobacter colitis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Endocrine disorders
Diabetes insipidus
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Enterococcal infection
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Pseudomonas infection
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Staphylococcal sepsis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
Other adverse events
| Measure |
Parsaclisib 1 mg QD
n=10 participants at risk
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.
|
Parsaclisib 2.5 mg QD
n=15 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Cardiac disorders
Angina pectoris
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Cardiac disorders
Arrhythmia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
20.0%
3/15 • Number of events 4 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Breath sounds abnormal
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
20.0%
3/15 • Number of events 6 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Renal and urinary disorders
Chromaturia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.0%
1/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Complement factor C4 decreased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • Number of events 5 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
33.3%
5/15 • Number of events 5 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Eosinophilic colitis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Gastroenteritis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 4 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 4 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Hepatobiliary disorders
Jaundice
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Lipids increased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Eye disorders
Macular oedema
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 4 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
2/10 • Number of events 4 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Reproductive system and breast disorders
Oedema genital
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
26.7%
4/15 • Number of events 4 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
20.0%
3/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
20.0%
3/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
General disorders
Pyrexia
|
40.0%
4/10 • Number of events 7 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
40.0%
6/15 • Number of events 6 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
20.0%
3/15 • Number of events 5 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
10.0%
1/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
20.0%
2/10 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
13.3%
2/15 • Number of events 3 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Nervous system disorders
Sciatica
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Total complement activity decreased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
10.0%
1/10 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
0.00%
0/15 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/10 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 1 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
6.7%
1/15 • Number of events 2 • up to a maximum of 1638 days
TEAEs (adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug) have been reported. As dose increases and decreases, based on clinical benefit and tolerability issues, respectively, were allowed during the course of the study for participants randomized to receive both 1 mg and 2.5 mg, AEs are reported per the treatment participants were randomized to rather than the dose level that was administered at the time the AE occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER