Trial Outcomes & Findings for Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (NCT NCT02443077)
NCT ID: NCT02443077
Last Updated: 2025-12-04
Results Overview
Will be assessed using the Lugano classification.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
Time between registration and disease progression or death, whichever comes first, assessed at 24 months
Results posted on
2025-12-04
Participant Flow
Participant milestones
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1. \> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> Carmustine: Given IV\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Etoposide: Given IV\> Ibrutinib: Given PO\> Laboratory Biomarker Analysis: Correlative studies\> Melphalan: Given IV\> Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
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\>\> Melphalan: Given IV\>
\>\>
\>\>
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\>\> Pharmacogenomic Study: Correlative studies\>
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\>\> Placebo Administration: Given PO
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Safety Cohort
AutoHCT + Ibrutinib (Cycle 1)\> \>\> Ibrutinib 560 mg† days -6 to -1\>
\>\> Ibrutinib Continuation\>
\>\> (Cycles 2-13)\*\*\>
\>\> Ibrutinib 560 mg daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
6
|
|
Overall Study
Crossover
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
10
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
35
|
34
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=45 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1. \> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> Carmustine: Given IV\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Etoposide: Given IV\> Ibrutinib: Given PO\> Laboratory Biomarker Analysis: Correlative studies\> Melphalan: Given IV\> Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=43 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
Safety Cohort
n=6 Participants
AutoHCT + Ibrutinib (Cycle 1) Ibrutinib 560 mg† days -6 to -1 Ibrutinib Continuation (Cycles 2-13)\*\* Ibrutinib 560 mg daily
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=3 Participants
|
59 years
n=3 Participants
|
52.5 years
n=6 Participants
|
61 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=3 Participants
|
20 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
41 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=3 Participants
|
23 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
53 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=3 Participants
|
40 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
89 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=3 Participants
|
39 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
80 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=3 Participants
|
|
Prior Ibrutinib
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
|
Time to relapse
<= 12 months (includes refractory)
|
21 Participants
n=3 Participants
|
21 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
47 Participants
n=3 Participants
|
|
Time to relapse
> 12 months
|
24 Participants
n=3 Participants
|
22 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
47 Participants
n=3 Participants
|
|
Type of transplant regimen planned
BEAM
|
42 Participants
n=3 Participants
|
41 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
88 Participants
n=3 Participants
|
|
Type of transplant regimen planned
CBV
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=3 Participants
|
|
Number of prior lines of chemo
|
2 chemo lines
n=3 Participants
|
2 chemo lines
n=3 Participants
|
2 chemo lines
n=6 Participants
|
2 chemo lines
n=3 Participants
|
|
ECOG Performance Status
0
|
14 Participants
n=3 Participants
|
18 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
34 Participants
n=3 Participants
|
|
ECOG Performance Status
1
|
27 Participants
n=3 Participants
|
23 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
54 Participants
n=3 Participants
|
|
ECOG Performance Status
2
|
4 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=3 Participants
|
|
LDH
|
251 U/L
n=3 Participants
|
229.5 U/L
n=3 Participants
|
292.5 U/L
n=6 Participants
|
235 U/L
n=3 Participants
|
|
Refractory Disease
|
10 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
20 Participants
n=3 Participants
|
|
Stage of Disease at Relapse
I
|
3 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=3 Participants
|
|
Stage of Disease at Relapse
II
|
11 Participants
n=3 Participants
|
7 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
19 Participants
n=3 Participants
|
|
Stage of Disease at Relapse
III
|
11 Participants
n=3 Participants
|
11 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
24 Participants
n=3 Participants
|
|
Stage of Disease at Relapse
IV
|
20 Participants
n=3 Participants
|
21 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
44 Participants
n=3 Participants
|
|
Baseline Deauville Score
Score 1-2
|
18 Participants
n=3 Participants
|
12 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
30 Participants
n=3 Participants
|
|
Baseline Deauville Score
Score 3-4
|
12 Participants
n=3 Participants
|
11 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
23 Participants
n=3 Participants
|
|
Baseline Deauville Score
Score 5
|
3 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
|
Extranodal Involvement
Bone marrow
|
7 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=3 Participants
|
|
Extranodal Involvement
Liver
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
|
Extranodal Involvement
Lung
|
6 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
|
Extranodal Involvement
Subcutaneous Tissue
|
4 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=3 Participants
|
|
Extranodal Involvement
Pleura
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
|
Extranodal Involvement
Spleen
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
|
Extranodal Involvement
Other
|
9 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
17 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Time between registration and disease progression or death, whichever comes first, assessed at 24 monthsPopulation: Participants that completed at least one cycle of treatment
Will be assessed using the Lugano classification.
Outcome measures
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=39 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1.\> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=38 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
|---|---|---|
|
24-month Progression-free Survival (PFS), Defined as the Proportion of Patients Who Are Alive and Progression-free 2 Years From Randomization
|
0.576 proportion of participants
Interval 0.421 to 0.788
|
0.408 proportion of participants
Interval 0.265 to 0.628
|
SECONDARY outcome
Timeframe: The time between randomization and death from any cause, assessed up to 5 years (60 months)For each arm, the distribution of OS will be estimated using the Kaplan-Meier method. OS will be compared between the two arms using the log-rank test and Cox regression method adjusting for the known predictors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First day of one week without platelet transfusion, assessed up to 5 yearsWill be defined as platelet count greater than or equal to 20,000/uL following nadir.
Outcome measures
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=39 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1.\> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=38 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
|---|---|---|
|
Time to Hematopoietic Engraftment
|
14.0 days
Interval 12.0 to 17.0
|
14.5 days
Interval 13.0 to 19.0
|
SECONDARY outcome
Timeframe: Time between registration and disease progression or death, whichever comes first, assessed up to 5 years (60 months)For each arm, the distribution of PFS will be estimated using the Kaplan-Meier method. PFS will be compared between the two arms using the log-rank test and Cox regression method adjusting for the known predictors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsThe metabolic response proportion following AutoHCT will be compared between the two arms using chi-squared test.
Outcome measures
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=39 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1.\> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=38 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
|---|---|---|
|
Response Rate Using the Lugano Classification
|
0.590 proportion of participants
Interval 0.421 to 0.744
|
0.553 proportion of participants
Interval 0.383 to 0.714
|
SECONDARY outcome
Timeframe: Up to 60 monthsTreatment-related mortality will be summarized using contingency tables.
Outcome measures
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=13 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1.\> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=12 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
|---|---|---|
|
Treatment-related Mortality
Disease-related
|
6 participants
|
8 participants
|
|
Treatment-related Mortality
Infection
|
4 participants
|
0 participants
|
|
Treatment-related Mortality
New Primary
|
1 participants
|
0 participants
|
|
Treatment-related Mortality
Other/Unknown
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsHematologic toxicity will be summarized using contingency tables.
Outcome measures
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=39 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1.\> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=38 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
|---|---|---|
|
Incidence of Hematologic Toxicity of Ibrutinib Therapy
Grade 3 Event
|
6 Participants
|
9 Participants
|
|
Incidence of Hematologic Toxicity of Ibrutinib Therapy
Grade 4 Event
|
13 Participants
|
11 Participants
|
|
Incidence of Hematologic Toxicity of Ibrutinib Therapy
Grade 5 Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsIncidence of secondary malignancies will be summarized using contingency tables.
Outcome measures
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=39 Participants
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen.\> BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1.\> CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.\> TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=38 Participants
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I.\> \>\>
TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0.\> \>\> \>\> \>\> \> \>\> \>\> \>\> CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Bone Marrow Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous hematopoietic progenitor cells or bone marrow transplant\> \>\> \>\> \>\> \> \>\> \>\> \>\> Carmustine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cyclophosphamide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Cytarabine: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Etoposide: Given IV\> \>\> \>\> \>\> \> \>\> \>\> \>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Melphalan: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Pharmacogenomic Study: Correlative studies\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Placebo Administration: Given PO
|
|---|---|---|
|
Incidence of Secondary Malignancies
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePFS and OS will be compared between PET/computed tomography (CT) positive and negative groups using the two-sample log-rank test with a 2-sided alpha of 5%. A Cox regression model will be conducted to regress PFS and OS on PET/CT positivity. Deauville criteria analyses will be conducted with cutoffs at scores of 2 and 3, and quantitative measurements, e.g. delta standard uptake value (SUV), %SUV decline and %MTV decline, in place of the dichotomous FDG-PET/CT outcome. Positive/negative predictive values, sensitivity and specificity of PET/CT further estimated by dichotomizing the PFS and OS at 2 years.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineGSTT1 null allele expression will be associated with carmustine toxicity. Quantified using the standard Common Terminology Criteria for Adverse Events and changes in diffusing capacity of the lungs for carbon monoxide from baseline.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAll SNPs will be evaluated for deviation from Hardy-Weinberg. In the absence of a hypothesized effect, analyses will be powered for allele dosing (i.e., additive) effects. The Cochran-Armitage test (for binary endpoints), Jonkheere-Terpstra test (for quantitative traits including biomarker or gene expressions in serum or tumor ribonucleic acid) and the Cox score test (for censored time-to-event outcomes) will be used to quantify marginal associations. Multivariable models, with molecular, clinical and demographic variables, will be constructed using conditional inference trees and random forests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe mutation of CD79a/b, caspase recruitment domain family, member 11 (CARD11), tumor necrosis factor, alpha-induced protein 3 TNFAIP3), and myeloid differentiation primary response 88 (MYD88) will be associated with each outcome in the ibrutinib arm (Arm A) using the chi-squared test for response rate and the log-rank test for each censored outcome. Similar analyses will be conducted for the placebo arm (Arm B) to show that the association between mutation and the outcomes observed in the ibrutinib arm is not observed in the placebo arm.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe expression of BCL2, MYC, and Ki67 will be analyzed to assess whether they affect clinical outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTranslocations in MYC with or without BCL2, and BCL6 will be analyzed to determine whether they are related to poor outcomes and whether ibrutinib modifies the prognosis.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Ibrutinib, Chemotherapy, autoHCT)
Serious events: 22 serious events
Other events: 36 other events
Deaths: 14 deaths
Arm II (Placebo, Chemotherapy, autoHCT)
Serious events: 23 serious events
Other events: 38 other events
Deaths: 10 deaths
Safety Cohort
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Crossover Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=45 participants at risk
Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=43 participants at risk
Placebo Administration: Given PO
|
Safety Cohort
n=6 participants at risk
AutoHCT + Ibrutinib (Cycle 1) Ibrutinib 560 mg† days -6 to -1 Ibrutinib Continuation (Cycles 2-13)\*\* Ibrutinib 560 mg daily
|
Crossover Arm
n=2 participants at risk
Pharmacogenomic Study: Correlative studies
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
50.0%
1/2 • Number of events 1 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
7.0%
3/43 • Number of events 3 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.3%
6/45 • Number of events 7 • Up to 60 months
|
9.3%
4/43 • Number of events 4 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
50.0%
1/2 • Number of events 1 • Up to 60 months
|
|
Gastrointestinal disorders
Colitis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
9.3%
4/43 • Number of events 4 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Mucositis oral
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Chills
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Fatigue
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Fever
|
11.1%
5/45 • Number of events 5 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Flu like symptoms
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Localized edema
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Device related infection
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Enterocolitis infectious
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
9.3%
4/43 • Number of events 4 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Lung infection
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Sepsis
|
6.7%
3/45 • Number of events 3 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/45 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Creatinine increased
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
50.0%
1/2 • Number of events 1 • Up to 60 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Platelet count decreased
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Anorexia
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/45 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Psychiatric disorders
Confusion
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
50.0%
1/2 • Number of events 1 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
7.0%
3/43 • Number of events 3 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Vascular disorders
Hypotension
|
6.7%
3/45 • Number of events 3 • Up to 60 months
|
2.3%
1/43 • Number of events 2 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
Other adverse events
| Measure |
Arm I (Ibrutinib, Chemotherapy, autoHCT)
n=45 participants at risk
Pharmacogenomic Study: Correlative studies
|
Arm II (Placebo, Chemotherapy, autoHCT)
n=43 participants at risk
Placebo Administration: Given PO
|
Safety Cohort
n=6 participants at risk
AutoHCT + Ibrutinib (Cycle 1) Ibrutinib 560 mg† days -6 to -1 Ibrutinib Continuation (Cycles 2-13)\*\* Ibrutinib 560 mg daily
|
Crossover Arm
n=2 participants at risk
Pharmacogenomic Study: Correlative studies
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/45 • Up to 60 months
|
4.7%
2/43 • Number of events 8 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
2.2%
1/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 3 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Conjunctivitis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Enterocolitis infectious
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
11.1%
5/45 • Number of events 9 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Lung infection
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Mucosal infection
|
4.4%
2/45 • Number of events 4 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Nail infection
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Injury, poisoning and procedural complications
Bruising
|
13.3%
6/45 • Number of events 13 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
7.0%
3/43 • Number of events 11 • Up to 60 months
|
33.3%
2/6 • Number of events 4 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Alkaline phosphatase increased
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
4.7%
2/43 • Number of events 10 • Up to 60 months
|
33.3%
2/6 • Number of events 4 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Cardiac troponin I increased
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Creatinine increased
|
2.2%
1/45 • Number of events 10 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Ejection fraction decreased
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Investigations - Other, specify
|
8.9%
4/45 • Number of events 15 • Up to 60 months
|
4.7%
2/43 • Number of events 5 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Lymphocyte count decreased
|
15.6%
7/45 • Number of events 13 • Up to 60 months
|
14.0%
6/43 • Number of events 16 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
50.0%
1/2 • Number of events 2 • Up to 60 months
|
|
Investigations
Lymphocyte count increased
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Neutrophil count decreased
|
35.6%
16/45 • Number of events 33 • Up to 60 months
|
34.9%
15/43 • Number of events 21 • Up to 60 months
|
33.3%
2/6 • Number of events 7 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Platelet count decreased
|
40.0%
18/45 • Number of events 46 • Up to 60 months
|
23.3%
10/43 • Number of events 28 • Up to 60 months
|
16.7%
1/6 • Number of events 9 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
Weight loss
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
7.0%
3/43 • Number of events 11 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Investigations
White blood cell decreased
|
26.7%
12/45 • Number of events 25 • Up to 60 months
|
14.0%
6/43 • Number of events 19 • Up to 60 months
|
33.3%
2/6 • Number of events 5 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Acidosis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
15/45 • Number of events 38 • Up to 60 months
|
39.5%
17/43 • Number of events 29 • Up to 60 months
|
66.7%
4/6 • Number of events 5 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
5/45 • Number of events 8 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.2%
1/45 • Number of events 5 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
6/45 • Number of events 8 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
3/45 • Number of events 3 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
10/45 • Number of events 16 • Up to 60 months
|
7.0%
3/43 • Number of events 3 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
5/45 • Number of events 7 • Up to 60 months
|
7.0%
3/43 • Number of events 9 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
3/45 • Number of events 3 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Metabolism and nutrition disorders
Obesity
|
4.4%
2/45 • Number of events 4 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
4.7%
2/43 • Number of events 4 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
2.3%
1/43 • Number of events 2 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
3/45 • Number of events 5 • Up to 60 months
|
2.3%
1/43 • Number of events 3 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • Number of events 8 • Up to 60 months
|
2.3%
1/43 • Number of events 3 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Dizziness
|
8.9%
4/45 • Number of events 6 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Dysgeusia
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
2.3%
1/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 4 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
3/45 • Number of events 5 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Spasticity
|
2.2%
1/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Psychiatric disorders
Anxiety
|
4.4%
2/45 • Number of events 6 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Psychiatric disorders
Confusion
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Psychiatric disorders
Depression
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Psychiatric disorders
Insomnia
|
11.1%
5/45 • Number of events 5 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.2%
1/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.1%
14/45 • Number of events 35 • Up to 60 months
|
27.9%
12/43 • Number of events 24 • Up to 60 months
|
66.7%
4/6 • Number of events 5 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
15/45 • Number of events 37 • Up to 60 months
|
23.3%
10/43 • Number of events 14 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/45 • Up to 60 months
|
9.3%
4/43 • Number of events 4 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/45 • Number of events 4 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
2/45 • Number of events 7 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.2%
1/45 • Number of events 4 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
26.7%
12/45 • Number of events 25 • Up to 60 months
|
16.3%
7/43 • Number of events 17 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
7.0%
3/43 • Number of events 6 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Vascular disorders
Hot flashes
|
2.2%
1/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Vascular disorders
Hypertension
|
8.9%
4/45 • Number of events 6 • Up to 60 months
|
9.3%
4/43 • Number of events 10 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Vascular disorders
Hypotension
|
8.9%
4/45 • Number of events 20 • Up to 60 months
|
9.3%
4/43 • Number of events 4 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Malaise
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Pain
|
6.7%
3/45 • Number of events 3 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Sinus tachycardia
|
8.9%
4/45 • Number of events 4 • Up to 60 months
|
11.6%
5/43 • Number of events 10 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Eye disorders
Eye disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
7.0%
3/43 • Number of events 5 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Colitis
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Constipation
|
26.7%
12/45 • Number of events 17 • Up to 60 months
|
27.9%
12/43 • Number of events 21 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Diarrhea
|
64.4%
29/45 • Number of events 60 • Up to 60 months
|
65.1%
28/43 • Number of events 52 • Up to 60 months
|
100.0%
6/6 • Number of events 8 • Up to 60 months
|
50.0%
1/2 • Number of events 2 • Up to 60 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.9%
4/45 • Number of events 5 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
4.4%
2/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Mucositis oral
|
13.3%
6/45 • Number of events 8 • Up to 60 months
|
4.7%
2/43 • Number of events 2 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Nausea
|
60.0%
27/45 • Number of events 59 • Up to 60 months
|
60.5%
26/43 • Number of events 40 • Up to 60 months
|
83.3%
5/6 • Number of events 8 • Up to 60 months
|
50.0%
1/2 • Number of events 1 • Up to 60 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Oral pain
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/45 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Gastrointestinal disorders
Vomiting
|
28.9%
13/45 • Number of events 18 • Up to 60 months
|
32.6%
14/43 • Number of events 19 • Up to 60 months
|
50.0%
3/6 • Number of events 4 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Chills
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Edema limbs
|
8.9%
4/45 • Number of events 11 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Fatigue
|
75.6%
34/45 • Number of events 111 • Up to 60 months
|
69.8%
30/43 • Number of events 78 • Up to 60 months
|
100.0%
6/6 • Number of events 13 • Up to 60 months
|
50.0%
1/2 • Number of events 1 • Up to 60 months
|
|
General disorders
Fever
|
40.0%
18/45 • Number of events 21 • Up to 60 months
|
46.5%
20/43 • Number of events 25 • Up to 60 months
|
83.3%
5/6 • Number of events 6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
General disorders
Gait disturbance
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
5/45 • Number of events 6 • Up to 60 months
|
11.6%
5/43 • Number of events 5 • Up to 60 months
|
33.3%
2/6 • Number of events 2 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
0.00%
0/45 • Up to 60 months
|
2.3%
1/43 • Number of events 1 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
1/45 • Number of events 2 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
5/45 • Number of events 7 • Up to 60 months
|
7.0%
3/43 • Number of events 5 • Up to 60 months
|
16.7%
1/6 • Number of events 1 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
4.4%
2/45 • Number of events 3 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Number of events 1 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.2%
1/45 • Number of events 5 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
1/45 • Number of events 6 • Up to 60 months
|
0.00%
0/43 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
18/45 • Number of events 50 • Up to 60 months
|
20.9%
9/43 • Number of events 20 • Up to 60 months
|
16.7%
1/6 • Number of events 6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
11.1%
5/45 • Number of events 11 • Up to 60 months
|
4.7%
2/43 • Number of events 10 • Up to 60 months
|
0.00%
0/6 • Up to 60 months
|
0.00%
0/2 • Up to 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60