Trial Outcomes & Findings for PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia (NCT NCT01589302)
NCT ID: NCT01589302
Last Updated: 2026-04-13
Results Overview
We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
up to 2 years
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Treatment (Ibrutinib)
Patients were treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. Patients received ibrutinib orally (PO) once daily(QD)on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
Del17p patients
|
76
|
|
Overall Study
Non-Del17p patients
|
76
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients were treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. Patients received ibrutinib orally (PO) once daily(QD)on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Age, Continuous
Del17p patients
|
66 years
n=193 Participants
|
|
Age, Continuous
Non-Del17p patients
|
64 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
152 patients
n=193 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients
We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.
All patients
|
64 percentage of patients
Interval 57.0 to 72.0
|
|
Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.
Del(17p)
|
64 percentage of patients
Interval 54.0 to 75.0
|
|
Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.
non-Del(17p)
|
64 percentage of patients
Interval 54.0 to 75.0
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients
Responders were subjects who achieved a complete response (CR), partial response (PR) or PR with persistent lymphocytosis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines
All patients
|
63 percentage of patients
Interval 55.0 to 70.0
|
|
Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines
Del(17p)
|
66 percentage of patients
Interval 55.0 to 76.0
|
|
Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines
non-Del(17p)
|
59 percentage of patients
Interval 48.0 to 70.0
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients
The 6 month overall response rates overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients
All patients
|
63 patients
Interval 55.0 to 70.0
|
|
Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients
Del(17p)
|
66 patients
Interval 55.0 to 76.0
|
|
Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients
Non-del(17p)
|
59 patients
Interval 48.0 to 70.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients
Time from date of first treatment with ibrutinib until the date of death from any cause or the date of last contact for those alive.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Percentage of Patients With Overall Survival (OS)
All patients
|
78 percent of patients
Interval 71.0 to 84.0
|
|
Percentage of Patients With Overall Survival (OS)
Del(17p)
|
75 percent of patients
Interval 63.0 to 83.0
|
|
Percentage of Patients With Overall Survival (OS)
non-Del(17p)
|
81 percent of patients
Interval 71.0 to 89.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients
Time from date of first treatment with ibrutinib until the date of progression or death from any cause. Those alive and progression free are censored at the date of last clinical assessment.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765
All patients
|
69 percent of patients
Interval 61.0 to 76.0
|
|
2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765
Del(17p)
|
66 percent of patients
Interval 54.0 to 76.0
|
|
2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765
non-Del(17p)
|
72 percent of patients
Interval 60.0 to 81.0
|
SECONDARY outcome
Timeframe: Up to 2 years post treatmentAdverse events grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with the attribution of either definite, possible or probable related.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Anemia
|
13 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Febrible Neutropenia
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Leukocytosis
|
18 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Atrial Fibrillation
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Diarrhea
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Gastric Hemorrhage
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Gastrointestinal Disorders-other
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Mucositis Oral
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Nausea
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Death
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Edema Limb
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Fatigue
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
General Disorders and Admin Site Conditions
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Cholecystitis
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Bronchial Infection
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Infections and Infestations-other
|
4 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Lung Infection
|
10 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Otitis Media
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Sepsis
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Skin Infection
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Urinary Tract Infection
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Alanine Aminotransferase Increased
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Blood Bilirubin Increased
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Lymphocyte Count Decreased
|
14 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Lymphocyte Count Increased
|
54 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Neutrophil Count Decreased
|
40 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Platelet Count Decreased
|
8 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
White Blood Cell Decreased
|
10 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hyperuricemia
|
4 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hypophosphatemia
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Arthralgia
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Arthritis
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hematuria
|
2 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hypoxia
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Respiratory Failure
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Rash Maculo-papular
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hematoma
|
1 patients
|
|
Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hypertension
|
7 patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPercentage of patients with BTK C481S mutation or PLCG2 mutation
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Resistance Studies of Ibrutinib
|
13.2 percentage of patients
Interval 8.2 to 19.6
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: Data was not collect and analyzed for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsThe number of participants with successful Allogenic Stem Cell Transplant
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data was reported for start of treatment only
Cancer-Specific Stress was measured by the Impact of Event Scale-Revised Participants rated the intensity of these feelings using a five-point Likert scale ranging from 0=not at all to 4=extremely. Patients rated the frequency of their feelings or events for the previous week before treatment. The items were summed for a total score that ranged from 0 to 64
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=152 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R)
|
9.18 units on a scale
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: at 5 monthsPopulation: Data was reported for month 5 from start of treatment
The Beck Depression Inventory-2nd edition is a 21-item measure of depressive symptoms. Scores were calculated representing the cognitive-affective and the somatic symptoms associated with depression (e.g. sadness, pessimism, loss of pleasure) during past month on scale from 0 to 3. Items were summed, with higher scores indicating more depressive symptoms. The scores on the scale from range from 0 to 42.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=130 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Cognitive-Affective Depressive Symptoms as Measured by the Beck Depression Inventory-2nd Edition (BDI-II)
|
1.88 units on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: at 5 monthsPopulation: Data was reported for month 5 from start of treatment
The Profile of Mood States-Short Form (POMS-SF) yields six subscales, Tension, Depression, Anger, Vigor, Fatigue, and Confusion. A total mood disturbance score is found by summing the six subscales. Total Mood Disturbance (TMD) scores range from -24 to 124 with higher scores indicating greater mood disturbance.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=128 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Negative Mood Quality of Life Measured by a 37-item Questionnaire
|
0.89 units on a scale
Standard Deviation 18.12
|
SECONDARY outcome
Timeframe: at 5 monthsSF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=126 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Mental Health Quality of Life Was Measured by the Mental Component Summary Score of the Medical Outcomes Study
|
53.98 units on a scale
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: at 5 monthsPopulation: Data was reported for month 5 from the start of treatment
The Fatigue Interference quality of life measures is a 11-item self reported questionnaire used to measure frequency, severity and daily pattern of fatigue Symptoms as well as impact of QOL in the past week. The Total Disruption Index (TDI) an 7 item subset of FSI was used. Items were rated on a 11-point Likert scale from 0=no interference to 10=extreme interference. Total scores could range from 0 to 70, with higher scores indicating greater fatigue interference.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=129 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Fatigue Symptom Inventory (FSI) Interference Quality of Life as Measured by a 11-item Total Disruption Index Sub Scale of Fatigue Symptoms Inventory
|
9.70 units on a scale
Standard Deviation 13.11
|
SECONDARY outcome
Timeframe: at 5 monthsPopulation: Data was reported for month 5 from start of treatment
Sleep problems quality of life measures is a six-item sleep problems index I of the Medical Outcomes Study-Sleep Scale used to assess sleep problems. Participants reported how often they experience six specific difficulties with sleep on a 6-point Likert scale (1=All of the time to 6=None of the time). Scores transformed into a 0-100 scale with higher scores indicating greater sleep problems.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=129 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Sleep Through Quality of Life as Measured by a Medical Outcomes Study-Sleep Scale
|
24.08 units on a scale
Standard Deviation 17.23
|
SECONDARY outcome
Timeframe: up to 5 monthsPopulation: Data was reported for month 5 from start of treatment
Physical Health Quality of life measures were administered during screening and on Days 1 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru Cycle 24 and at time of progression and /or end of treatment. SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=126 Participants
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
|
|---|---|
|
Physical Health Quality of Life as Measured by a 12 Item Short-Form Health Survey
|
44.23 units on a scale
Standard Deviation 11.31
|
Adverse Events
Treatment (Ibrutinib)
Serious events: 152 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Ibrutinib)
n=152 participants at risk
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progres
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.3%
5/152 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome
|
0.66%
1/152 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrest
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Cardiac Disorders-other
|
0.66%
1/152 • Number of events 4
|
|
Cardiac disorders
Myocardial Infarction
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Ventricular Arrythmia
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
3/152 • Number of events 3
|
|
Gastrointestinal disorders
Enterocolitis
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal Ulcer
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Disorders-other
|
2.0%
3/152 • Number of events 4
|
|
Gastrointestinal disorders
Jejunal Hemorrhage
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.3%
2/152 • Number of events 2
|
|
Gastrointestinal disorders
Chills
|
0.66%
1/152 • Number of events 1
|
|
General disorders and administration site conditions
Death NOS
|
3.3%
5/152 • Number of events 5
|
|
General disorders and administration site conditions
Edema Limbs
|
0.66%
1/152 • Number of events 1
|
|
General disorders and administration site conditions
Fatigue
|
0.66%
1/152 • Number of events 1
|
|
General disorders and administration site conditions
Fever
|
2.6%
4/152 • Number of events 4
|
|
General disorders and administration site conditions
General Disorders and Administration Site Conditions - Other
|
2.0%
3/152 • Number of events 3
|
|
General disorders and administration site conditions
Non-Cardiac Chest Pain
|
0.66%
1/152 • Number of events 1
|
|
General disorders and administration site conditions
Sudden Death NOS
|
0.66%
1/152 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
2/152 • Number of events 4
|
|
Immune system disorders
Immune System Disorders - Other
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Bone Infection
|
2.0%
3/152 • Number of events 3
|
|
Infections and infestations
Bronchial Infection
|
2.6%
4/152 • Number of events 4
|
|
Infections and infestations
Catheter Related Infection
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Enterocolitis Infectious
|
2.0%
3/152 • Number of events 3
|
|
Infections and infestations
Infections and Infestations-other
|
8.6%
13/152 • Number of events 16
|
|
Infections and infestations
Lung Infection
|
21.1%
32/152 • Number of events 53
|
|
Infections and infestations
Otitis Media
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Sepsis
|
3.9%
6/152 • Number of events 7
|
|
Infections and infestations
Sinusitis
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Skin Infection
|
2.6%
4/152 • Number of events 4
|
|
Infections and infestations
Soft Tissue Infection
|
1.3%
2/152 • Number of events 3
|
|
Infections and infestations
Upper Respiratory Infection
|
3.3%
5/152 • Number of events 5
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
3/152 • Number of events 8
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications - Other
|
2.0%
3/152 • Number of events 3
|
|
Injury, poisoning and procedural complications
Intestinal Stoma Obstruction
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative Hemorrhage
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
3/152 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
2/152 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders - Other
|
2.6%
4/152 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/152 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
3/152 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Left Sided
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other
|
2.0%
3/152 • Number of events 3
|
|
Nervous system disorders
Intracranial Hemorrhage
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Leukoencephalopathy
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Memory Impairement
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Nervous System Disorders - Other
|
2.0%
3/152 • Number of events 4
|
|
Nervous system disorders
Syncope
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Transient Ischemic Attacks
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Psychiatric Disorders-Other
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.66%
1/152 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders - Other
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and Mediastinal Disorders - Other
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Surgical and Medical Procedures - Other
|
2.6%
4/152 • Number of events 4
|
|
Vascular disorders
Hematoma
|
0.66%
1/152 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Superior Vena Cava Syndrom
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Thromboembolic Events
|
1.3%
2/152 • Number of events 2
|
|
Vascular disorders
Vascular Disorders- Other
|
0.66%
1/152 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Ibrutinib)
n=152 participants at risk
Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.
ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progres
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.3%
43/152 • Number of events 51
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.4%
25/152 • Number of events 29
|
|
Blood and lymphatic system disorders
Lymph node pain
|
9.2%
14/152 • Number of events 16
|
|
Cardiac disorders
Atrial Fibrillation
|
8.6%
13/152 • Number of events 15
|
|
Cardiac disorders
Palpitations
|
7.9%
12/152 • Number of events 15
|
|
Cardiac disorders
Sinus Bradycardia
|
15.8%
24/152 • Number of events 28
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
9/152 • Number of events 11
|
|
Ear and labyrinth disorders
Ear and Labyrinth disorders
|
6.6%
10/152 • Number of events 12
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.3%
8/152 • Number of events 8
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
8/152 • Number of events 8
|
|
Eye disorders
Blurred vision
|
12.5%
19/152 • Number of events 21
|
|
Eye disorders
Cataract
|
8.6%
13/152 • Number of events 13
|
|
Eye disorders
Conjunctivitis
|
5.3%
8/152 • Number of events 9
|
|
Eye disorders
Dry eye
|
7.9%
12/152 • Number of events 13
|
|
Eye disorders
Eye Disorders
|
23.0%
35/152 • Number of events 41
|
|
Eye disorders
Watering eyes
|
5.3%
8/152 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.4%
34/152 • Number of events 39
|
|
Gastrointestinal disorders
Bloating
|
15.8%
24/152 • Number of events 24
|
|
Gastrointestinal disorders
Constipation
|
33.6%
51/152 • Number of events 66
|
|
Gastrointestinal disorders
Diarrhea
|
65.8%
100/152 • Number of events 190
|
|
Gastrointestinal disorders
Dry mouth
|
9.9%
15/152 • Number of events 15
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
15/152 • Number of events 17
|
|
Gastrointestinal disorders
Dysphagia
|
6.6%
10/152 • Number of events 10
|
|
Gastrointestinal disorders
Flatulence
|
11.2%
17/152 • Number of events 18
|
|
Gastrointestinal disorders
Gastrointestional Disorder
|
48.0%
73/152 • Number of events 103
|
|
Gastrointestinal disorders
Mucositis
|
46.1%
70/152 • Number of events 127
|
|
Gastrointestinal disorders
Nausea
|
36.8%
56/152 • Number of events 86
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
18.4%
28/152 • Number of events 37
|
|
Gastrointestinal disorders
Oral Pain
|
4.6%
7/152 • Number of events 8
|
|
Gastrointestinal disorders
Stomach Pain
|
6.6%
10/152 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
27.0%
41/152 • Number of events 59
|
|
General disorders
Chills
|
23.7%
36/152 • Number of events 42
|
|
General disorders
Edema Limbs
|
32.2%
49/152 • Number of events 59
|
|
General disorders
Fatigue
|
54.6%
83/152 • Number of events 99
|
|
General disorders
Fever
|
27.0%
41/152 • Number of events 55
|
|
General disorders
Flu Like Symptoms
|
8.6%
13/152 • Number of events 15
|
|
General disorders
General Disorders
|
17.8%
27/152 • Number of events 34
|
|
General disorders
Non-Cardiac chest pain
|
7.9%
12/152 • Number of events 12
|
|
General disorders
Pain
|
21.7%
33/152 • Number of events 42
|
|
Infections and infestations
Bronchial Infection
|
11.8%
18/152 • Number of events 21
|
|
Infections and infestations
Eye Infection
|
5.3%
8/152 • Number of events 9
|
|
Infections and infestations
Infections and Infestations
|
21.1%
32/152 • Number of events 41
|
|
Infections and infestations
Lung Infection
|
19.7%
30/152 • Number of events 43
|
|
Infections and infestations
Nail Infection
|
5.9%
9/152 • Number of events 9
|
|
Infections and infestations
Paronychia
|
7.2%
11/152 • Number of events 18
|
|
Infections and infestations
Sinusitis
|
32.2%
49/152 • Number of events 68
|
|
Infections and infestations
Skin Infection
|
23.0%
35/152 • Number of events 43
|
|
Infections and infestations
Upper Respiratory Infection
|
47.4%
72/152 • Number of events 129
|
|
Infections and infestations
Urinary Tract Infection
|
19.7%
30/152 • Number of events 52
|
|
Injury, poisoning and procedural complications
Bruising
|
46.1%
70/152 • Number of events 93
|
|
Injury, poisoning and procedural complications
Fall
|
13.2%
20/152 • Number of events 32
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and procedural complications
|
4.6%
7/152 • Number of events 7
|
|
Investigations
Lymphocyte count decreased
|
16.4%
25/152 • Number of events 36
|
|
Investigations
Lymphocyte count increased
|
46.1%
70/152 • Number of events 87
|
|
Investigations
Neutrophil count decreased
|
52.6%
80/152 • Number of events 166
|
|
Investigations
Platelet count decreased
|
28.9%
44/152 • Number of events 52
|
|
Investigations
Weight gain
|
42.8%
65/152 • Number of events 75
|
|
Investigations
Weight loss
|
25.7%
39/152 • Number of events 53
|
|
Investigations
White Blood cell decreased
|
17.8%
27/152 • Number of events 38
|
|
Metabolism and nutrition disorders
Anorexia
|
25.7%
39/152 • Number of events 39
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.2%
17/152 • Number of events 30
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
8/152 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.2%
17/152 • Number of events 25
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
9/152 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.2%
14/152 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.9%
12/152 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.8%
56/152 • Number of events 77
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
15.8%
24/152 • Number of events 26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.3%
37/152 • Number of events 41
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.9%
12/152 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective tissue disorder-other
|
68.4%
104/152 • Number of events 123
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.1%
29/152 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
9/152 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity
|
19.1%
29/152 • Number of events 34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified-other
|
24.3%
37/152 • Number of events 49
|
|
Nervous system disorders
Dizziness
|
36.2%
55/152 • Number of events 69
|
|
Nervous system disorders
Dysgeusia
|
11.2%
17/152 • Number of events 18
|
|
Nervous system disorders
Headache
|
41.4%
63/152 • Number of events 79
|
|
Nervous system disorders
Nervous System Disorders-other
|
6.6%
10/152 • Number of events 10
|
|
Nervous system disorders
Paresthesia
|
31.6%
48/152 • Number of events 54
|
Additional Information
Kami Maddocks, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3507
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place