Trial Outcomes & Findings for A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma (NCT NCT01776840)

NCT ID: NCT01776840

Last Updated: 2025-07-08

Results Overview

Progression-free survival (PFS) was defined as the interval between the date of randomization to the date of disease progression (PD) or relapse from complete response (CR) or death, whichever was first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD was defined as any new lesion or increase by 50 percent (%) of previously involved sites from nadir (PD criteria: Appearance of new nodal lesion 1.5 centimeters \[cm\] in any axis, 50% increase in sum of product of diameters \[SPD\] of greater than \[\>\] 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 523 participants
• Primary outcome timeframe: Up to 97 months
• Results posted on: 2025-07-08

Participant Flow

A total of 523 subjects were randomized in this study.

Participant milestones

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Overall Study STARTED	262	261
Overall Study Safety Analysis Set (Treated)	260	259
Overall Study COMPLETED	129	119
Overall Study NOT COMPLETED	133	142

Reasons for withdrawal

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Overall Study Lost to Follow-up	12	7
Overall Study Withdrawal by Subject	32	48
Overall Study Sponsor decision	89	87

Baseline Characteristics

A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

Baseline characteristics by cohort

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.	Total n=523 Participants Total of all reporting groups
Age, Continuous	71.7 years STANDARD_DEVIATION 5.2 • n=5 Participants	71.8 years STANDARD_DEVIATION 5.04 • n=7 Participants	71.7 years STANDARD_DEVIATION 5.12 • n=5 Participants
Age, Customized 70 years and over	154 Participants n=5 Participants	162 Participants n=7 Participants	316 Participants n=5 Participants
Age, Customized < 70 years	108 Participants n=5 Participants	99 Participants n=7 Participants	207 Participants n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	83 Participants n=7 Participants	159 Participants n=5 Participants
Sex: Female, Male Male	186 Participants n=5 Participants	178 Participants n=7 Participants	364 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	234 Participants n=5 Participants	232 Participants n=7 Participants	466 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	42 Participants n=5 Participants	47 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 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
Race/Ethnicity, Customized White	206 Participants n=5 Participants	199 Participants n=7 Participants	405 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment ARGENTINA	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment AUSTRALIA	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment BELGIUM	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment BRAZIL	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment CANADA	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment CHINA	26 Participants n=5 Participants	31 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment CZECH REPUBLIC	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment FRANCE	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment GERMANY	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment GREECE	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment HUNGARY	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment IRELAND	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment ISRAEL	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment ITALY	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment JAPAN	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment MEXICO	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment NETHERLANDS	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment POLAND	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment SLOVAKIA	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment SOUTH KOREA	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment SPAIN	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment SWEDEN	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment TAIWAN	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment TURKEY	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment UKRAINE	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment UNITED STATES	48 Participants n=5 Participants	35 Participants n=7 Participants	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 97 months

Population: Intent-to-treat (ITT) analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Here, N (overall number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

Progression-free survival (PFS) was defined as the interval between the date of randomization to the date of disease progression (PD) or relapse from complete response (CR) or death, whichever was first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD was defined as any new lesion or increase by 50 percent (%) of previously involved sites from nadir (PD criteria: Appearance of new nodal lesion 1.5 centimeters [cm] in any axis, 50% increase in sum of product of diameters [SPD] of greater than [>] 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis).

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Progression-free Survival (PFS)	52.9 months Interval 43.7 to 71.0	80.6 months Interval 61.9 to Here, 'NA' refers that the upper limit of 95% confidence interval was not estimable because of small number of events.

SECONDARY outcome

Timeframe: From randomization (Day -3) up to 121 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received.

Overall survival was defined as the time from the date of randomization to the date of the participant's death. Kaplan-Meier estimate was used.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Overall Survival	95.9 months Interval 86.1 to 115.3	104.3 months Interval 81.1 to Here, 'NA' refers that the upper limit of 95% confidence interval was not estimable because of small number of participants with events.

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received.

Complete response (CR) rate was defined as the percentage of participants who achieve CR (based on investigator assessment) on or prior to the initiation of subsequent anticancer therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on computed tomography (CT); spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Complete Response Rate	57.6 percentage of participants	65.5 percentage of participants

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

Time-to-next treatment was measured from the date of randomization to the start date of any anti-mantle cell lymphoma (anti-MCL) treatment subsequent to the study treatment.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Time-to-Next Treatment	92.0 months Interval 71.5 to Here, 'NA' refers that the upper limit of 95% confidence interval was not estimable due to a small number of participants with events.	NA months Here, 'NA' refers that the median and 95% confidence interval were not estimable due to a small number of participants with events.

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received.

Percentage of participants with overall response was defined as the portion of participants who achieved CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. Criteria for PR: greater than or equal to (>=) 50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Percentage of Participants With Overall Response	88.5 percentage of participants	89.7 percentage of participants

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. CR participants with missing MRD data and participants who did not achieve a CR were considered nonresponders.

Minimal residual disease negative rate was defined as the percentage of participants with a best overall response of CR with MRD-negative disease status (that is, <5 mantle cell lymphoma [MCL] cell per 10,000 leukocytes for detection using the MRD assay), as assessed by flow cytometry of a bone marrow and/or peripheral blood sample.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Minimal Residual Disease (MRD)-Negative Response Rate	56.5 percentage of participants	62.1 percentage of participants

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received.

Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline, death, or a missing assessment due to being "too ill", whichever occurred first. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score was the total of reverse scores, ranged 0 to 60. Higher scores indicated a better quality of life.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=262 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=261 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Questionnaire	22.2 months Interval 9.3 to 34.0	17.4 months Interval 8.3 to 27.6

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Participants who achieved a PR or better were included in the analysis of duration of response.

Duration of Response (DoR) was defined as the interval between the date of initial documentation of a response including PR and the date of first documented evidence of PD or death

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=232 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=234 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Duration of Response (DoR)	63.5 months Interval 47.0 to 76.9	81 months Interval 64.2 to Here, 'NA' refers that the upper limit of 95% confidence interval was not estimable due to a small number of participants with events.

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Participants who achieved a CR or better were included in the analysis of duration of complete response.

Duration of complete response (DoCR) was defined as the interval between the date of initial documentation of a CR and the date of first documented evidence of PD or death whichever occurs first.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=151 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=171 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Duration of Complete Response (DoCR)	78.1 months Interval 65.6 to Here, 'NA' refers that the upper limit of 95% confidence interval were not estimable due to a small number of participants with events.	NA months Interval 81.7 to Here, 'NA' refers that the median and upper limit of 95% confidence interval were not estimable due to a small number of participants with events.

SECONDARY outcome

Timeframe: Up to 97 months

Population: ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Participants who achieved a PR or better were included in the analysis of time to response.

Time to response was defined as the interval between the date of randomization and the date of initial documentation of a response.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=232 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=234 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Time to Response	2.79 months Interval 1.9 to 11.2	2.79 months Interval 2.1 to 10.1

SECONDARY outcome

Timeframe: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).

Number of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication, or the initiation of subsequent anticancer therapy, whichever is earlier.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=260 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=259 Participants Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	257 Participants	259 Participants

SECONDARY outcome

Timeframe: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Population: Pharmacokinetic-evaluable population included participants who have received at least 1 dose of ibrutinib/placebo and had at least 1 pharmacokinetic sample obtained posttreatment.

CL/F was defined as apparent total systemic clearance of ibrutinib after extravascular administration. Cl/F of Ibrutinib was determined using population pharmacokinetics (PopPK modeling).

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=259 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Oral Plasma Clearance (CL/F) of Ibrutinib	1123 liter per hour (L/h) Standard Error 4.83	—

SECONDARY outcome

Timeframe: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Population: Pharmacokinetic-evaluable population included participants who have received at least 1 dose of ibrutinib/placebo and had at least 1 pharmacokinetic sample obtained posttreatment.

Oral volume of distribution at steady state of ibrutinib was determined using PopPK modeling.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=259 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Oral Volume of Distribution at Steady State of Ibrutinib	7286 liter Standard Error 7.87	—

SECONDARY outcome

Timeframe: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Population: Pharmacokinetic-evaluable population included participants who have received at least 1 dose of ibrutinib/placebo and had at least 1 pharmacokinetic sample obtained posttreatment.

Area under the concentration curve of ibrutinib during 24 hours after dosing at steady state was determined using PopPK modeling.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=259 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Area Under the Concentration Curve of Ibrutinib During 24 Hours After Dosing at Steady State	425 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 267	—

SECONDARY outcome

Timeframe: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Population: Pharmacokinetic-evaluable population included participants who have received at least 1 dose of ibrutinib/placebo and had at least 1 pharmacokinetic sample obtained posttreatment.

Minimum observed plasma concentration of ibrutinib was determined using PopPK modeling.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=259 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Minimum Observed Plasma Concentration of Ibrutinib	3.90 nanograms per milliliter (ng/mL) Standard Deviation 2.64	—

SECONDARY outcome

Timeframe: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Population: Pharmacokinetic-evaluable population included participants who have received at least 1 dose of ibrutinib/placebo and had at least 1 pharmacokinetic sample obtained posttreatment.

Maximum observed plasma concentration of ibrutinib was determined using PopPK modeling.

Outcome measures

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=259 Participants Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Maximum Observed Plasma Concentration of Ibrutinib	74.5 ng/mL Standard Deviation 48.3	—

Adverse Events

Placebo + Bendamustine and Rituximab (BR) (Treatment A)

Serious events: 157 serious events

Other events: 255 other events

Deaths: 129 deaths

Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B)

Serious events: 201 serious events

Other events: 256 other events

Deaths: 120 deaths

Serious adverse events

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=260 participants at risk Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=259 participants at risk Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Blood and lymphatic system disorders Anaemia	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Febrile Neutropenia	3.5% 9/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Lymphadenitis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Methaemoglobinaemia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Neutropenia	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Pancytopenia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Splenic Infarction	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Thrombocytopenia	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Acute Coronary Syndrome	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Acute Myocardial Infarction	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Angina Pectoris	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Arrhythmia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Atrial Fibrillation	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.4% 14/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Atrial Flutter	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Atrioventricular Block	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Bradycardia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Cardiac Arrest	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Cardiac Failure	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Cardiomyopathy	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Cardiopulmonary Failure	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Coronary Artery Disease	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Coronary Artery Stenosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Ischaemic Cardiomyopathy	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Left Ventricular Failure	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Mitral Valve Stenosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Myocardial Infarction	2.3% 6/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Myocardial Ischaemia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Nodal Rhythm	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Pericardial Effusion	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Silent Myocardial Infarction	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Sinus Bradycardia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Sinus Node Dysfunction	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Supraventricular Tachycardia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Ventricular Extrasystoles	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Congenital, familial and genetic disorders Odontogenic Cyst	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Endocrine disorders Hyperaldosteronism	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Cataract	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Exophthalmos	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Retinal Detachment	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Ulcerative Keratitis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Abdominal Pain	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Acute Abdomen	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Anal Haemorrhage	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Colitis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Constipation	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Dental Caries	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Diarrhoea	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.1% 8/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Gastric Perforation	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Gastric Ulcer	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Gastritis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Gastritis Haemorrhagic	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Haematochezia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Ileus	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Inguinal Hernia	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Intestinal Obstruction	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Intestinal Perforation	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Mouth Haemorrhage	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Mouth Ulceration	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Nausea	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Proctitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Umbilical Hernia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Vomiting	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Asthenia	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Chest Discomfort	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Chest Pain	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Chills	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Death	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Fatigue	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders General Physical Health Deterioration	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Localised Oedema	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Malaise	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Mucosal Inflammation	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Multiple Organ Dysfunction Syndrome	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Non-Cardiac Chest Pain	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Oedema Peripheral	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Pyrexia	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	7.3% 19/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Sudden Death	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Hepatobiliary disorders Cholecystitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Hepatobiliary disorders Cholecystitis Acute	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Hepatobiliary disorders Cholelithiasis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Hepatobiliary disorders Hepatic Function Abnormal	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Immune system disorders Anaphylactic Reaction	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Immune system disorders Drug Hypersensitivity	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Immune system disorders Hypersensitivity	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Immune system disorders Serum Sickness	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Abscess Intestinal	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Abscess Limb	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Appendicitis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Arthritis Bacterial	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Bacterial Sepsis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Bronchitis	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	2.7% 7/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Bronchopulmonary Aspergillosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Campylobacter Gastroenteritis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Campylobacter Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Candida Sepsis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Cellulitis	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.5% 9/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Clostridium Colitis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Clostridium Difficile Colitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Clostridium Difficile Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Covid-19	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Covid-19 Pneumonia	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.1% 8/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Cystitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Cytomegalovirus Colitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Cytomegalovirus Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Device Related Infection	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Diverticulitis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Epididymitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Epiglottitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Erysipelas	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Escherichia Bacteraemia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Escherichia Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Fungal Oesophagitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Gastroenteritis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Gastroenteritis Salmonella	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Gastroenteritis Viral	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Hepatitis B	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Hepatitis B Reactivation	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Herpes Zoster	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Herpes Zoster Disseminated	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Herpes Zoster Oticus	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Histoplasmosis Disseminated	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Infective Exacerbation of Chronic Obstructive Airways Disease	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Influenza	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Listeriosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Localised Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Lower Respiratory Tract Infection	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Lung Abscess	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Meningococcal Bacteraemia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Moraxella Infection	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Nosocomial Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Oesophageal Candidiasis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Oral Candidiasis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Oropharyngeal Candidiasis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Osteomyelitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Osteomyelitis Chronic	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Otitis Media	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Parasitic Gastroenteritis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Paronychia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Periorbital Cellulitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pharyngitis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumococcal Bacteraemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumocystis Jirovecii Pneumonia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia	13.5% 35/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	22.4% 58/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Aspiration	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Bacterial	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Cytomegaloviral	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Fungal	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Pneumococcal	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Pseudomonal	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia Viral	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Postoperative Wound Infection	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Progressive Multifocal Leukoencephalopathy	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pseudomembranous Colitis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pseudomonas Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pulmonary Sepsis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pulmonary Tuberculosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pyelonephritis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pyelonephritis Chronic	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Respiratory Syncytial Virus Infection	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Respiratory Tract Infection	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Sepsis	2.3% 6/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.9% 10/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Septic Shock	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Sialoadenitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Sinusitis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Sinusitis Bacterial	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Sinusitis Fungal	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Skin Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Soft Tissue Infection	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Staphylococcal Bacteraemia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Staphylococcal Infection	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Staphylococcal Sepsis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Streptococcal Bacteraemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Suspected Covid-19	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Toxoplasmosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Upper Respiratory Tract Infection	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Urinary Tract Infection	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	2.7% 7/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Urosepsis	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Vascular Device Infection	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Facial Bones Fracture	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Fall	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Head Injury	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Humerus Fracture	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Infusion Related Reaction	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Limb Injury	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Skin Laceration	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Spinal Fracture	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Stoma Complication	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Subdural Haematoma	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Toxicity to Various Agents	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Traumatic Intracranial Haemorrhage	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Wound	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Alanine Aminotransferase Increased	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Aspartate Aminotransferase Increased	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Blood Creatinine Increased	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Bronchoscopy	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Cytomegalovirus Test Positive	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Gastrointestinal Stoma Output Increased	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Neutrophil Count Decreased	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Platelet Count Decreased	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Scan Abnormal	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Decreased Appetite	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Dehydration	1.9% 5/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.5% 4/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Diabetes Mellitus	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Gout	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hyperglycaemia	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hyperkalaemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hypoglycaemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hypokalaemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hyponatraemia	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Metabolic Acidosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Tumour Lysis Syndrome	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Back Pain	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Finger Deformity	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Flank Pain	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Jaw Cyst	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Muscular Weakness	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Myalgia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Osteoporosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Osteoporotic Fracture	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Spinal Disorder	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Gastric	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix Cancer	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Anorectal Neoplasm	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myelomonocytic Leukaemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal Adenocarcinoma	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Langerhans' Cell Histiocytosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Squamous Cell Carcinoma	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Malignant Melanoma	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular Neoplasm	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Squamous Cell Carcinoma Metastatic	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Lung	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Amnesia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Amyotrophic Lateral Sclerosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Brain Oedema	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Carotid Artery Stenosis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Central Nervous System Lesion	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Cerebral Ischaemia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Cerebrovascular Accident	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Dizziness	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Facial Paralysis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Haemorrhagic Stroke	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Headache	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Ischaemic Stroke	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Lacunar Stroke	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Loss of Consciousness	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Peripheral Motor Neuropathy	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Post Herpetic Neuralgia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Presyncope	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Quadriplegia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Seizure	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Spinal Cord Compression	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Subarachnoid Haemorrhage	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Syncope	1.9% 5/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Thalamic Infarction	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Transient Global Amnesia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Transient Ischaemic Attack	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Vascular Encephalopathy	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Product Issues Device End of Service	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Anxiety	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Confusional State	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Delirium	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Depression	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Acute Kidney Injury	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.1% 8/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Calculus Urinary	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Haematuria	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Renal Colic	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Renal Cyst Haemorrhage	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Renal Impairment	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.2% 3/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Urinary Retention	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Reproductive system and breast disorders Balanoposthitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Reproductive system and breast disorders Prostatic Obstruction	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Reproductive system and breast disorders Prostatitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Asthma	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.9% 5/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Hypersensitivity Pneumonitis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Organising Pneumonia	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	2.7% 7/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Tonsillar Disorder	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Actinic Keratosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Dermatitis Bullous	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Diabetic Foot	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Drug Reaction with Eosinophilia and Systemic Symptoms	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Rash	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	1.9% 5/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Urticaria	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Surgical and medical procedures Coronary Artery Bypass	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Surgical and medical procedures Tracheostomy Closure	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Aortic Stenosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Arterial Thrombosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Deep Vein Thrombosis	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.00% 0/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Embolism	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Giant Cell Arteritis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Haematoma	0.38% 1/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Hypertension	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Hypertensive Crisis	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Hypertensive Urgency	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Hypotension	0.77% 2/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.77% 2/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Peripheral Artery Aneurysm	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Raynaud's Phenomenon	0.00% 0/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	0.39% 1/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).

Other adverse events

Measure	Placebo + Bendamustine and Rituximab (BR) (Treatment A) n=260 participants at risk Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.	Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) n=259 participants at risk Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
Blood and lymphatic system disorders Anaemia	23.1% 60/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	32.0% 83/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Leukopenia	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	10.4% 27/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Lymphopenia	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.9% 18/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Neutropenia	40.0% 104/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	42.1% 109/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Blood and lymphatic system disorders Thrombocytopenia	16.5% 43/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	23.9% 62/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Atrial Fibrillation	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	12.4% 32/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Cardiac disorders Palpitations	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.5% 9/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Ear and labyrinth disorders Vertigo	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	4.2% 11/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Cataract	6.5% 17/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.1% 21/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Dry Eye	1.9% 5/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Eye disorders Vision Blurred	3.8% 10/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.4% 14/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Abdominal Pain	11.2% 29/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	9.7% 25/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Abdominal Pain Upper	3.8% 10/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	7.3% 19/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Constipation	25.4% 66/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	20.1% 52/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Diarrhoea	36.9% 96/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	45.9% 119/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Dry Mouth	2.3% 6/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.9% 18/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Dyspepsia	8.1% 21/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.1% 21/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Gastrooesophageal Reflux Disease	6.2% 16/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.9% 18/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Nausea	41.2% 107/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	42.1% 109/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Stomatitis	2.3% 6/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.9% 23/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Gastrointestinal disorders Vomiting	18.5% 48/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	21.6% 56/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Asthenia	9.6% 25/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	11.6% 30/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Chest Pain	4.6% 12/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.4% 14/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Chills	15.0% 39/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.6% 17/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Fatigue	29.6% 77/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	30.5% 79/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Influenza Like Illness	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.4% 14/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Malaise	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	4.6% 12/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Mucosal Inflammation	5.8% 15/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.4% 14/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Oedema Peripheral	16.2% 42/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	19.3% 50/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
General disorders Pyrexia	29.2% 76/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	34.0% 88/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Immune system disorders Hypogammaglobulinaemia	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.5% 9/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Bronchitis	13.8% 36/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	12.7% 33/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Cellulitis	1.5% 4/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.8% 15/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Conjunctivitis	2.3% 6/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	10.0% 26/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Covid-19	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.6% 17/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Herpes Zoster	10.4% 27/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.8% 15/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Influenza	6.2% 16/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.5% 9/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Lower Respiratory Tract Infection	3.5% 9/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.0% 13/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Nasopharyngitis	10.8% 28/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	9.7% 25/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Oral Candidiasis	2.7% 7/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	7.3% 19/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Pneumonia	15.0% 39/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	20.5% 53/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Rhinitis	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	3.9% 10/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Sinusitis	13.1% 34/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	9.7% 25/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Skin Infection	1.9% 5/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.9% 18/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Upper Respiratory Tract Infection	26.5% 69/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	27.0% 70/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Infections and infestations Urinary Tract Infection	12.3% 32/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	13.9% 36/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Contusion	4.6% 12/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.9% 23/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Fall	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Injury, poisoning and procedural complications Infusion Related Reaction	10.0% 26/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	7.3% 19/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Alanine Aminotransferase Increased	4.6% 12/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.9% 23/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Aspartate Aminotransferase Increased	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	9.3% 24/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Blood Creatinine Increased	8.5% 22/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.9% 23/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Lymphocyte Count Decreased	10.0% 26/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	12.4% 32/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Neutrophil Count Decreased	16.5% 43/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	15.1% 39/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Platelet Count Decreased	10.8% 28/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	15.8% 41/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations Weight Decreased	7.7% 20/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	10.0% 26/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Investigations White Blood Cell Count Decreased	13.1% 34/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	11.6% 30/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Decreased Appetite	13.8% 36/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	20.8% 54/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hyperglycaemia	3.8% 10/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.8% 15/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hyperuricaemia	7.7% 20/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	9.3% 24/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hypocalcaemia	2.7% 7/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.6% 17/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hypokalaemia	11.5% 30/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	15.1% 39/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Metabolism and nutrition disorders Hypomagnesaemia	6.9% 18/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	9.3% 24/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Arthralgia	16.9% 44/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	17.8% 46/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Back Pain	14.6% 38/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	13.9% 36/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Muscle Spasms	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.1% 21/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Muscular Weakness	1.9% 5/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.8% 15/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Myalgia	11.5% 30/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	12.7% 33/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Musculoskeletal and connective tissue disorders Pain in Extremity	9.2% 24/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.9% 18/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	4.6% 12/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Dizziness	7.3% 19/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.5% 22/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Headache	15.4% 40/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	12.7% 33/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Nervous system disorders Paraesthesia	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.0% 13/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Anxiety	6.5% 17/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.4% 14/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Depression	4.6% 12/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Psychiatric disorders Insomnia	10.8% 28/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	11.2% 29/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Renal and urinary disorders Haematuria	2.7% 7/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Cough	32.7% 85/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	30.1% 78/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.3% 45/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	10.4% 27/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 13/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	12.0% 31/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	5.4% 14/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	2.7% 7/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	9.2% 24/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.9% 23/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Respiratory, thoracic and mediastinal disorders Productive Cough	6.9% 18/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Dry Skin	4.2% 11/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.1% 21/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Erythema	4.6% 12/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	5.0% 13/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Pruritus	21.5% 56/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	18.1% 47/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Rash	21.9% 57/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	36.7% 95/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Rash Maculo-Papular	3.8% 10/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.5% 22/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Skin Lesion	4.2% 11/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Skin and subcutaneous tissue disorders Urticaria	2.7% 7/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	6.2% 16/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Haematoma	1.2% 3/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	7.7% 20/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Hypertension	11.2% 29/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	14.3% 37/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
Vascular disorders Hypotension	6.2% 16/260 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).	8.5% 22/259 • All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).

Additional Information

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Email: ClinicalTrialDisclosure@its.jnj.com

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.
• Publication restrictions are in place

Restriction type: OTHER