Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease (NCT NCT02436135)
NCT ID: NCT02436135
Last Updated: 2020-09-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
First dose date up to 28 days
Results posted on
2020-09-16
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 05 June 2015. The last study visit occurred on 20 November 2017.
12 participants were screened. Participants were enrolled in Cohorts A and B. After the fourth participant in Cohort B was enrolled, the study was terminated. No additional participants were enrolled.
Participant milestones
| Measure |
Cohort A, Idelalisib + Ruxolitinib
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for primary myelofibrosis (PMF), post- polycythemia vera (PV) myelofibrosis (MF), or post-essential thrombocythemia (ET) MF.
|
Cohort B, Idelalisib + Ruxolitinib
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Cohort A, Idelalisib + Ruxolitinib
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for primary myelofibrosis (PMF), post- polycythemia vera (PV) myelofibrosis (MF), or post-essential thrombocythemia (ET) MF.
|
Cohort B, Idelalisib + Ruxolitinib
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
1
|
|
Overall Study
Investigator Discretion
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Participant
|
1
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease
Baseline characteristics by cohort
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
69 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
65 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Full Analysis Set included all participants who took at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure
|
100.0 Percentage of participants
|
75.0 Percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure
|
33.3 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in the Full Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 3)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 2)
|
33.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 3)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 2)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 3)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 1)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 1)
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 1)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 1)
|
16.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 1)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 1)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 2)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 1)
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 4)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date (maximum:15.1 months) plus 30 daysPopulation: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date (maximum:15.1 months) plus 30 daysPopulation: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date (maximum:15.1 months) plus 30 daysPopulation: Participants in the Full Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 3)
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 1)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 3)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 3)
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 4)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 2)
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 3)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 2)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 3)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Platelet count decreased (Grade 4)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 1)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 3)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 1)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 1)
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 1)
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 1)
|
16.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 1)
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 2)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Increased (Grade 3)
|
16.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase Transferase (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 3)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 1)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoglycemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypomagnesemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 2)
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperkalemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 1)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 3)
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 4)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 1)
|
33.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 4)
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date (maximum:15.1 months) plus 30 daysPopulation: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Beyond 28 Days of Exposure
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Start of treatment to end of treatment ( up to 15.1 months)Population: The study was prematurely terminated due to safety measures. Complete data were not collected for any participant.
Rate of overall response as defined by 2013 Revised International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose Week 2, 1.5 hour Week 2, and Predose Week 3Population: The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and have at least 1 nonmissing postdose value reported by the PK laboratory.
Outcome measures
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 Participants
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 Participants
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
Idelalisib: Predose Week 2
|
9.95 ng/mL
Standard Deviation 6.534
|
106.83 ng/mL
Standard Deviation 107.549
|
|
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
Idelalisib: 1.5 hour Postdose Week 2
|
835.00 ng/mL
Standard Deviation 487.102
|
760.25 ng/mL
Standard Deviation 438.644
|
|
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
Idelalisib: Predose Week 3
|
6.67 ng/mL
Standard Deviation 1.770
|
90.25 ng/mL
Standard Deviation 85.374
|
|
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
GS-563117: Predose Week 2
|
396.6 ng/mL
Standard Deviation 406.95
|
1156.8 ng/mL
Standard Deviation 1252.69
|
|
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
GS-563117: 1.5 hour Postdose Week 2
|
1051.4 ng/mL
Standard Deviation 692.36
|
1405.5 ng/mL
Standard Deviation 1228.45
|
|
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
GS-563117: Predose Week 3
|
227.9 ng/mL
Standard Deviation 212.10
|
988.0 ng/mL
Standard Deviation 1018.05
|
Adverse Events
Cohort A, Idelalisib + Ruxolitinib
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort B, Idelalisib + Ruxolitinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 participants at risk
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 participants at risk
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Cohort A, Idelalisib + Ruxolitinib
n=6 participants at risk
Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
|
Cohort B, Idelalisib + Ruxolitinib
n=4 participants at risk
Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
|
|---|---|---|
|
General disorders
Chest pain
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
*Anaemia
|
33.3%
2/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
2/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
50.0%
2/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
50.0%
2/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chills
|
33.3%
2/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
50.0%
3/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
50.0%
2/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus decreased
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
2/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
3/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
50.0%
2/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
50.0%
2/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
1/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
16.7%
1/6 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/4 • First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Full Analysis Set included all participants who took at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER