Trial Outcomes & Findings for A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies (NCT NCT02329847)
NCT ID: NCT02329847
Last Updated: 2025-05-25
Results Overview
ORR is percentage of participants achieving a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR) or PR. IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L, Hgb \>11 g/dL and absolute lymphocyte count \<4000/mcL; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- \>=50% drop in lymphocyte count from baseline or \<=4.0\*10\^9/L with following: \>=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, \>=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils \>1.5\*10\^9/L, Platelets\>100000/mcL and Hgb\>11 g/dL or \>=50% improvement over baseline in all. This outcome measure was planned to be analyzed for specified arm only.
COMPLETED
PHASE1/PHASE2
144 participants
Up to 6 years 11 months
2025-05-25
Participant Flow
Participant milestones
| Measure |
Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
36
|
35
|
39
|
20
|
|
Overall Study
Treated (Safety Analysis Set)
|
7
|
7
|
35
|
35
|
37
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
35
|
35
|
39
|
20
|
Reasons for withdrawal
| Measure |
Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
4
|
22
|
12
|
20
|
13
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
3
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
5
|
7
|
8
|
3
|
|
Overall Study
Other
|
1
|
2
|
6
|
13
|
10
|
3
|
Baseline Characteristics
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
n=7 Participants
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=7 Participants
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
n=35 Participants
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=35 Participants
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=37 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=20 Participants
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 18.08 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 13.96 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 11.94 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 15.99 • n=21 Participants
|
64.9 years
STANDARD_DEVIATION 11.19 • n=10 Participants
|
62.2 years
STANDARD_DEVIATION 12.94 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
87 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
134 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
134 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
AUSTRALIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Region of Enrollment
ISRAEL
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Region of Enrollment
POLAND
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Region of Enrollment
SPAIN
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Region of Enrollment
TURKEY
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Region of Enrollment
UNITED STATES
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 6 years 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). The ORR evaluation criteria were disease specific and hence the analysis was done as per disease cohorts for this outcome measure as pre-planned.
ORR is percentage of participants achieving a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR) or PR. IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L, Hgb \>11 g/dL and absolute lymphocyte count \<4000/mcL; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- \>=50% drop in lymphocyte count from baseline or \<=4.0\*10\^9/L with following: \>=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, \>=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils \>1.5\*10\^9/L, Platelets\>100000/mcL and Hgb\>11 g/dL or \>=50% improvement over baseline in all. This outcome measure was planned to be analyzed for specified arm only.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=30 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort
|
63.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 years 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). The ORR evaluation criteria were disease specific and hence the analysis was done as per disease cohorts for this outcome measure as pre-planned.
ORR defined as percentage of participants achieving a CR, CRi, nPR or PR. As per Non-Hodgkin Lymphoma, Cheson 2014, CR is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive disease (PD) \>= 50% increase from nadir in the sum of the products of at least two lymph nodes, or appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=6 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=40 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=45 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=20 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort
|
50.0 Percentage of Participants
|
32.5 Percentage of Participants
|
37.8 Percentage of Participants
|
65.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 years 10 monthsPopulation: The safety population included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs for the treatment phase included events with an onset date/time on or after the start of study intervention through end of study were considered as treatment-emergent.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=7 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=7 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=35 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=35 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=37 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=20 Participants
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
97.3 Percentage of Participants
|
95.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 6 years 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and achieved either PR or better (including PRL only for CLL participants).
DOR is defined as the interval between the date of initial documentation of a response including partial response with lymphocytosis (PRL) and date of first documented evidence of progressive disease or death or date of censoring. iWCLL 2008 criteria for progressive disease: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; \>= 50% increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (\>=5\*10\^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=2 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=1 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=26 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=12 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=15 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=13 Participants
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DoR): Study Cohort
|
11.5 Months
Interval 2.4 to 20.7
|
NA Months
Here 'NA' indicates that median and 95% CI could not be estimated due to less number of participants with events.
|
19.2 Months
Interval 9.4 to 19.4
|
10.2 Months
Interval 5.1 to 17.8
|
NA Months
Interval 4.6 to
Here 'NA' indicates that median and upper limit of 95% CI could not be estimated due to less number of participants with events.
|
6.9 Months
Interval 1.3 to
Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 6 years and 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and met criteria for progressive disease. Here 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
Duration of stable disease or better was defined as duration from the start of the treatment until the criteria for progression were met. IWCLL 2008 criteria for progressive disease: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; \>= 50% increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=1 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=1 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=5 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=7 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=1 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Duration of Stable Disease or Better: Study Cohort
|
24.8 Months
Interval 24.8 to 24.8
|
20.8 Months
Interval 20.8 to 20.8
|
17.38 Months
Interval 14.0 to 21.6
|
14.55 Months
Interval 12.7 to 20.4
|
14.1 Months
Interval 14.1 to 14.1
|
—
|
SECONDARY outcome
Timeframe: Up to 6 years 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and met criteria for progressive disease.
PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. IWCLL 2008 criteria for progressive disease: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; \>= 50% increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=6 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=5 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=16 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=26 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=22 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=11 Participants
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS): Study Cohort
|
2.0 Months
Interval 1.1 to 24.8
|
9.1 Months
Interval 0.7 to 20.8
|
21.6 Months
Interval 12.0 to 21.6
|
7.6 Months
Interval 2.9 to 12.7
|
3.2 Months
Interval 2.1 to
Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
|
5.0 Months
Interval 2.4 to
Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 6 years 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and were responders.
OS was defined as duration from the date of first dose of study drug to the date of the participant's death.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=4 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=3 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=11 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=9 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=16 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=8 Participants
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS): Study Cohort
|
12.4 Months
Interval 2.0 to 28.8
|
NA Months
Interval 0.8 to
Here 'NA' indicates that median and upper limit of 95% CI could not be estimated due to less number of participants with events.
|
NA Months
Interval 21.6 to
Here 'NA' indicates that median and upper limit of 95% CI could not be estimated due to less number of participants with events.
|
NA Months
Here 'NA' indicates that median and 95% CI could not be estimated due to less number of participants with events.
|
19.0 Months
Interval 7.7 to
Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
|
10.3 Months
Interval 4.8 to
Here 'NA' indicates that upper limit of 95% CI could not be estimated due to less number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 6 years 11 monthsPopulation: The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab).
Percentage of participants with lymphoma-related symptoms were reported. These symptoms included B-symptoms, recurrent fever, night sweats, weight loss, other disease-related symptoms, itching, fatigue, physical discomfort and any other.
Outcome measures
| Measure |
Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL)
n=7 Participants
Participants with CLL in Cohort A1 and B1, received ibrutinib 420 milligrams (mg) capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Follicular Lymphoma (FL)
n=7 Participants
Participants with FL in Cohorts A1, A2, and B2, and who had histologically confirmed initial diagnosis of FL, received ibrutinib either 420 or 560 mg capsules orally, daily starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilograms (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL)
n=35 Participants
Participants with DLBCL in Cohorts A1, A2, and B3, and who had histologically confirmed disease with at least 1 measurable disease site, received ibrutinib either 420 or 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Ibrutinib and Nivolumab: Richter
n=35 Participants
Participants who had histologically confirmed Richter syndrome in Cohort B4 with at least 1 site of measurable disease, received ibrutinib 560 mg capsules orally, daily starting on Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=37 Participants
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=20 Participants
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Lymphoma-related Symptoms: Study Cohort
|
14.3 Percentage of Participants
|
42.9 Percentage of Participants
|
74.3 Percentage of Participants
|
25.7 Percentage of Participants
|
54.1 Percentage of Participants
|
60.0 Percentage of Participants
|
Adverse Events
Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
Serious adverse events
| Measure |
Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
n=7 participants at risk
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=7 participants at risk
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
n=35 participants at risk
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=35 participants at risk
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=37 participants at risk
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=20 participants at risk
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Atrial Fibrillation
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Cardiotoxicity
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Eye disorders
Cataract
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Oesophageal Compression
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Asthenia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Chest Pain
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Chills
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
General Physical Health Deterioration
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Unevaluable Event
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Hepatobiliary disorders
Bile Duct Stone
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Hepatobiliary disorders
Cholecystitis
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Bacteraemia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Covid-19
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Encephalitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Otitis Media
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Otitis Media Chronic
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Septic Shock
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Wound Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Injury, poisoning and procedural complications
Pancreatic Injury
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Immunoglobulins Decreased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Transaminases Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic Infiltration
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile Squamous Cell Carcinoma
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
Other adverse events
| Measure |
Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
n=7 participants at risk
Participants with chronic lymphocytic leukemia (CLL)/ follicular cell lymphoma (FL)/diffuse large B-cell lymphoma (DLBCL), received ibrutinib 420 milligrams (mg) capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kilogram (kg) as an intravenous (IV) infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=7 participants at risk
Participants with FL/DLBCL, received ibrutinib 560 mg capsule orally once daily starting from Day 1 of Cycle 1 up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg
n=35 participants at risk
Participants with CLL/small lymphocytic lymphoma (SLL) with deletion (del) 17p or 11q, received ibrutinib 420 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=35 participants at risk
Participants with FL, received ibrutinib 560 mg orally once daily, starting at 7 days prior to Day 1 of Cycle 1 as a run-in period and then daily thereafter up to 56 cycles (26 months). Participants also received nivolumab 3 mg/kg as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=37 participants at risk
Participants with DLBCL, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg
n=20 participants at risk
Participants with richter syndrome, received ibrutinib 560 mg orally once daily, starting from Day 1 of Cycle 1 up to 56 cycles (26 months), along with nivolumab 3 mg/kg administered as an IV infusion on Day 1 of each cycle up to 56 cycles. Each cycle was of 14 days.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Immune system disorders
Secondary Immunodeficiency
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Bronchitis
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
25.7%
9/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
29.7%
11/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
40.0%
8/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
57.1%
20/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
7/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
27.0%
10/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
40.0%
8/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
31.4%
11/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
18.9%
7/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
15.0%
3/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Endocrine disorders
Euthyroid Sick Syndrome
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Eye disorders
Miosis
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Anal Ulcer
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
71.4%
5/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
37.1%
13/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
34.3%
12/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
32.4%
12/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
25.0%
5/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Dyspepsia
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gastric Fistula
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Intra-Abdominal Haematoma
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Melaena
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
7/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
24.3%
9/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
16.2%
6/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Asthenia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Chills
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Fatigue
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
42.9%
3/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
17.1%
6/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
40.0%
14/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
29.7%
11/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Gait Disturbance
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Generalised Oedema
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Inflammation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Influenza Like Illness
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Oedema Peripheral
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
7/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
15.0%
3/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Peripheral Swelling
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
General disorders
Pyrexia
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
10/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
24.3%
9/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
30.0%
6/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Covid-19
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Fungal Skin Infection
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Gallbladder Abscess
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Herpes Simplex
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Klebsiella Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Otitis Media
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Paronychia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
31.4%
11/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
10/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
18.9%
7/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
35.0%
7/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Viral Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Viral Pharyngitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Wound Infection
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Injury, poisoning and procedural complications
Nasal Injury
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
4/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Amylase Increased
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
4/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Alkaline Phosphatase
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Creatinine Increased
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Lipase Increased
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
22.9%
8/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
15.0%
3/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Serum Ferritin Decreased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Investigations
Weight Decreased
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.8%
4/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
22.9%
8/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
17.1%
6/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
18.9%
7/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
25.0%
5/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
10/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
24.3%
9/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
17.1%
6/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Dizziness Postural
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
57.1%
4/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
31.4%
11/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
13.5%
5/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
4/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.8%
4/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.8%
4/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
28.6%
2/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.1%
3/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.0%
2/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
10.8%
4/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
17.1%
6/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
22.9%
8/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
29.7%
11/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
20.0%
4/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
8.6%
3/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.7%
2/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Haematoma
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
5/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Haemorrhage
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.7%
1/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
11.4%
4/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
2.9%
1/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.4%
2/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
15.0%
3/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Pallor
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
Phlebitis
|
14.3%
1/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
|
Vascular disorders
White Coat Hypertension
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/7 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/35 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
0.00%
0/37 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
5.0%
1/20 • Up to 6 years 11 months
All-cause mortality was assessed on all randomized participants. Serious adverse events and other adverse events were assessed on safety analysis set which included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab).
|
Additional Information
Executive Medical Director
Janssen Research & Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER