Trial Outcomes & Findings for Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma (NCT NCT02242097)
NCT ID: NCT02242097
Last Updated: 2024-03-12
Results Overview
PFS will be measured from start of treatment to time of progression. Evidence of clinical progression will be documented by imaging (CT scan) for patients who have measurable disease. Progression is defined using the LUGANO Criteria, as a Deauville score of 4 or 5 (increased uptake compared to baseline) or the appearance of new lesions
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Assessed at 3 years
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Treatment (Ibrutinib)
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Ibrutinib Treatment
STARTED
|
37
|
|
Ibrutinib Treatment
Cycle 1
|
36
|
|
Ibrutinib Treatment
Cycle 2
|
36
|
|
Ibrutinib Treatment
Cycle 4
|
34
|
|
Ibrutinib Treatment
Cycle 7
|
33
|
|
Ibrutinib Treatment
Cycle 13
|
30
|
|
Ibrutinib Treatment
Cycle 19
|
26
|
|
Ibrutinib Treatment
Cycle 25
|
25
|
|
Ibrutinib Treatment
Cycle 37
|
18
|
|
Ibrutinib Treatment
Cycle 49
|
17
|
|
Ibrutinib Treatment
COMPLETED
|
17
|
|
Ibrutinib Treatment
NOT COMPLETED
|
20
|
|
Post Therapy Follow Up
STARTED
|
36
|
|
Post Therapy Follow Up
COMPLETED
|
32
|
|
Post Therapy Follow Up
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Ibrutinib)
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Ibrutinib Treatment
Adverse Event
|
16
|
|
Ibrutinib Treatment
Physician Decision
|
1
|
|
Ibrutinib Treatment
Lack of Efficacy
|
1
|
|
Ibrutinib Treatment
Death
|
1
|
|
Ibrutinib Treatment
Patient Ineligible to start treatment
|
1
|
|
Post Therapy Follow Up
Death
|
3
|
|
Post Therapy Follow Up
Lost to Follow-up
|
1
|
Baseline Characteristics
Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib)
n=36 Participants
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
ECOG Score
0-1
|
34 Participants
n=5 Participants
|
|
ECOG Score
2
|
2 Participants
n=5 Participants
|
|
Stage at initial diagnosis
I/II
|
5 Participants
n=5 Participants
|
|
Stage at initial diagnosis
III/IV
|
28 Participants
n=5 Participants
|
|
Stage at initial diagnosis
Unknown
|
3 Participants
n=5 Participants
|
|
MIPI score
Low
|
18 Participants
n=5 Participants
|
|
MIPI score
Intermediate
|
7 Participants
n=5 Participants
|
|
MIPI score
High
|
11 Participants
n=5 Participants
|
|
Extranodal disease at diagnosis
|
9 Participants
n=5 Participants
|
|
Auto-SCT consolidation prior to enrollment
|
18 Participants
n=5 Participants
|
|
Induction Therapy
BR
|
17 Participants
n=5 Participants
|
|
Induction Therapy
R-HyperCVAD
|
9 Participants
n=5 Participants
|
|
Induction Therapy
Nordic Regimen
|
7 Participants
n=5 Participants
|
|
Induction Therapy
R-CHOP/DHAP
|
2 Participants
n=5 Participants
|
|
Induction Therapy
R-CHOP
|
1 Participants
n=5 Participants
|
|
Best response to induction therapy prior to enrollment
CR
|
34 Participants
n=5 Participants
|
|
Best response to induction therapy prior to enrollment
PR
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 3 yearsPFS will be measured from start of treatment to time of progression. Evidence of clinical progression will be documented by imaging (CT scan) for patients who have measurable disease. Progression is defined using the LUGANO Criteria, as a Deauville score of 4 or 5 (increased uptake compared to baseline) or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=36 Participants
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Determine the Progression-free Survival (PFS) Rate After 3 Years
|
94 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatment, maximum 4 years post-first doseTo assess toxicity, all adverse events will be summarized as to type, severity, frequency, timing and attribution. Treatment related Adverse Events Occurring with Incidence of greater that or equal to 20% of patients treated with Ibrutinib Maintenance are shown here.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=36 Participants
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Atrial Fibrillation/Atrial Flutter · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Infection · Grade 1
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Infection · Grade 2
|
22 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Infection · Grade 3
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Infection · Grade 4
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Infection · Grade 0
|
5 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Decreased · Grade 1
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Decreased · Grade 2
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Decreased · Grade 3
|
12 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Decreased · Grade 4
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Decreased · Grade 0
|
7 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
White blood cells decreased · Grade 1
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
White blood cells decreased · Grade 2
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
White blood cells decreased · Grade 3
|
7 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
White blood cells decreased · Grade 4
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
White blood cells decreased · Grade 0
|
10 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea · Grade 1
|
21 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea · Grade 2
|
3 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea · Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea · Grade 0
|
12 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Platelet Count Decreased · Grade 1
|
22 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Platelet Count Decreased · Grade 2
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Platelet Count Decreased · Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Platelet Count Decreased · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Platelet Count Decreased · Grade 0
|
13 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil Count Decreased · Grade 1
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil Count Decreased · Grade 2
|
7 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil Count Decreased · Grade 3
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil Count Decreased · Grade 4
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil Count Decreased · Grade 0
|
15 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hypertension · Grade 1
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hypertension · Grade 2
|
8 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hypertension · Grade 3
|
8 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hypertension · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hypertension · Grade 0
|
16 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hemorrhage · Grade 1
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hemorrhage · Grade 2
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hemorrhage · Grade 3
|
2 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hemorrhage · Grade 4
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Hemorrhage · Grade 0
|
20 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Skin Rash · Grade 1
|
14 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Skin Rash · Grade 2
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Skin Rash · Grade 3
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Skin Rash · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Skin Rash · Grade 0
|
20 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Bruising · Grade 1
|
13 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Bruising · Grade 2
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Bruising · Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Bruising · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Bruising · Grade 0
|
23 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Myalgia · Grade 1
|
10 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Myalgia · Grade 2
|
3 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Myalgia · Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Myalgia · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Myalgia · Grade 0
|
23 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Fatigue · Grade 1
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Fatigue · Grade 2
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Fatigue · Grade 3
|
2 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Fatigue · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Fatigue · Grade 0
|
24 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Anemia · Grade 1
|
8 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Anemia · Grade 2
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Anemia · Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Anemia · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Anemia · Grade 0
|
24 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Aspartate Aminotransferase increased · Grade 1
|
9 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Aspartate Aminotransferase increased · Grade 2
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Aspartate Aminotransferase increased · Grade 3
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Aspartate Aminotransferase increased · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Aspartate Aminotransferase increased · Grade 0
|
25 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Atrial Fibrillation/Atrial Flutter · Grade 1
|
1 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Atrial Fibrillation/Atrial Flutter · Grade 2
|
5 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Atrial Fibrillation/Atrial Flutter · Grade 3
|
4 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Atrial Fibrillation/Atrial Flutter · Grade 0
|
26 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase increased · Grade 1
|
8 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase increased · Grade 2
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase increased · Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase increased · Grade 4
|
0 Participants
|
|
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase increased · Grade 0
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsProgression will be evaluated using Cheson 2007 criteria, only patients who had a PR at the time of registration and who complete ≥ 1 complete cycle of ibrutinib maintenance therapy will be evaluable for this endpoint.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=2 Participants
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Rate of Conversion From Partial Response (PR) to Complete Response (CR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 years post-first dosePatients will be evaluated monthly for the first 6 months on treatment, then every 3 months thereafter. Patients who go off treatment will continue to be followed for up to 4 years post-first dose. Follow-up will occur every 3 months (up to 2 years after the first dose of treatment) and then every 6 months thereafter (up to 4 years post-first dose). OS after 4 years will be calculated as a percentage of patient alive.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=36 Participants
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS) After 4 Years
|
94 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Four time-points: baseline (pre-treatment), after 1 month and 6 months of treatment, and approximately 18-24 months post-first dose of treatmentArchived tissue from a previous biopsy from all patients will be obtained for baseline clone identification; in addition, peripheral whole blood samples will be collected at four time points. MRD analysis will be conducted using PCR methods and results will be compared over time and correlated with PFS and OS.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ibrutinib)
Serious events: 22 serious events
Other events: 36 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Ibrutinib)
n=36 participants at risk
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Atrial flutter
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Ventricular fibrillation
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Edema limbs
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Fatigue
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Lung infection
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Pharyngitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Skin infection
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Cardiac troponin I increased
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Ejection fraction decreased
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Neutrophil count decreased
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Platelet count decreased
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
White blood cell decreased
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Transient ischemic attacks
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Confusion
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Social circumstances
Social circumstances - Other, specify
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Hematoma
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Superior vena cava syndrome
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
Other adverse events
| Measure |
Treatment (Ibrutinib)
n=36 participants at risk
Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
ibrutinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.6%
29/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Atrial flutter
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Chest pain - cardiac
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Mobitz type I
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Palpitations
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Pericardial effusion
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Pericardial tamponade
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Ear and labyrinth disorders
Ear pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Blurred vision
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Conjunctivitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Dry eye
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Eye disorders - Other, specify
|
25.0%
9/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Keratitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Scleral disorder
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Eye disorders
Vitreous hemorrhage
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
22.2%
8/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
27/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
25.0%
9/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
9/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Stomach pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Chills
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Edema face
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Edema limbs
|
33.3%
12/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Facial pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Fatigue
|
55.6%
20/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Fever
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Flu like symptoms
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
25.0%
9/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Infusion site extravasation
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Injection site reaction
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Localized edema
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Malaise
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Non-cardiac chest pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
General disorders
Pain
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Immune system disorders
Allergic reaction
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Immune system disorders
Autoimmune disorder
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Bronchial infection
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Eye infection
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
36.1%
13/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Laryngitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Lung infection
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Otitis media
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Papulopustular rash
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Paronychia
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Pharyngitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Rash pustular
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Rhinitis infective
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Scrotal infection
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Sinusitis
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Skin infection
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Upper respiratory infection
|
44.4%
16/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Infections and infestations
Urinary tract infection
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
38.9%
14/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
36.1%
13/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
9/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
16/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Blood bilirubin increased
|
36.1%
13/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Cardiac troponin I increased
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Creatinine increased
|
30.6%
11/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
INR increased
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Investigations - Other, specify
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Lymphocyte count decreased
|
91.7%
33/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Neutrophil count decreased
|
66.7%
24/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Platelet count decreased
|
77.8%
28/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Weight gain
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
Weight loss
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Investigations
White blood cell decreased
|
80.6%
29/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Acidosis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
72.2%
26/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.6%
11/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
38.9%
14/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
19.4%
7/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.8%
10/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.6%
11/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.6%
11/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
6/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
41.7%
15/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.4%
16/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
9/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Dizziness
|
27.8%
10/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Dysgeusia
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Headache
|
27.8%
10/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Memory impairment
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Neuralgia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Paresthesia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Sinus pain
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Spasticity
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Nervous system disorders
Syncope
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Anxiety
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Confusion
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Delirium
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Depression
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Insomnia
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Libido decreased
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Restlessness
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Psychiatric disorders
Suicidal ideation
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Renal and urinary disorders
Hematuria
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Renal and urinary disorders
Proteinuria
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Renal and urinary disorders
Urinary urgency
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.2%
17/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.1%
13/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
30.6%
11/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
22.2%
8/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
13.9%
5/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
12/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
50.0%
18/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Flushing
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Hematoma
|
11.1%
4/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Hot flashes
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Hypertension
|
75.0%
27/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Hypotension
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Superior vena cava syndrome
|
2.8%
1/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
8.3%
3/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
5.6%
2/36 • All adverse events are collected from the date of initial informed consent until 30 days after the last dose of study treatment, up to 4 years
|
Additional Information
Dr. Reem Karmali
Northwestern University, Feinberg School of Medicine
Phone: (312) 695-0990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place