Trial Outcomes & Findings for Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma (NCT NCT02947347)
NCT ID: NCT02947347
Last Updated: 2026-03-17
Results Overview
PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014, Lugano Classification\]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
445 participants
Primary outcome timeframe
Primary Analysis cut-off; median overall follow-up of 53.75 months
Results posted on
2026-03-17
Participant Flow
In total, 445 participants were enrolled at 128 sites in 19 countries. Participants were randomly assigned in a 3:1 ratio to the Ibrutinib + Rituximab arm (Arm A; n=334) or the Placebo + Rituximab arm (Arm B; n=111). Randomization was stratified on the basis of: (a) age (60-69 vs. ≥70 years), (b) Follicular Lymphoma-specific International Prognostic Index (FLIPI)-1 score (low vs. intermediate/high) and (c) ECOG performance status score (0/1 vs. 2).
The intent-to-treat (ITT) population included all randomized participants. The ITT population was the primary population for all efficacy analyses (N=445). The safety population included all participants who received at least one dose of study treatment (N=441).
Participant milestones
| Measure |
Arm A: Ibrutinib + Rituximab
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
334
|
111
|
|
Overall Study
On Study Treatment at Study Closure
|
50
|
22
|
|
Overall Study
Off Treatment and on Follow-up at Study Closure
|
108
|
33
|
|
Overall Study
COMPLETED
|
158
|
55
|
|
Overall Study
NOT COMPLETED
|
176
|
56
|
Reasons for withdrawal
| Measure |
Arm A: Ibrutinib + Rituximab
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Death
|
109
|
35
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Withdrawal of Consent
|
50
|
14
|
|
Overall Study
Other
|
10
|
3
|
Baseline Characteristics
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.7 Years
STANDARD_DEVIATION 6.38 • n=10 Participants
|
74.2 Years
STANDARD_DEVIATION 5.96 • n=50 Participants
|
73.8 Years
STANDARD_DEVIATION 6.28 • n=108 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=10 Participants
|
53 Participants
n=50 Participants
|
236 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=10 Participants
|
58 Participants
n=50 Participants
|
209 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=10 Participants
|
8 Participants
n=50 Participants
|
27 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
304 Participants
n=10 Participants
|
103 Participants
n=50 Participants
|
407 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
11 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=10 Participants
|
10 Participants
n=50 Participants
|
23 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
304 Participants
n=10 Participants
|
97 Participants
n=50 Participants
|
401 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=10 Participants
|
3 Participants
n=50 Participants
|
18 Participants
n=108 Participants
|
PRIMARY outcome
Timeframe: Primary Analysis cut-off; median overall follow-up of 53.75 monthsPopulation: ITT Population. Participants achieving response (partial response or better) who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored.
PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014, Lugano Classification\]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Investigator
|
42.02 months
Interval 33.31 to 50.83
|
32.76 months
Interval 22.05 to 38.67
|
SECONDARY outcome
Timeframe: Primary Analysis; median overall follow-up of 53.75 monthsPopulation: ITT population
ORR is the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) as determined by the investigator according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014, Lugano Classification). ORR was assessed from the date of randomization through the date of first documented disease progression or initiation of subsequent anti-cancer therapy, whichever occurred first. Participants who did not have any post-baseline disease assessments or who initiated subsequent anti-cancer therapy prior to a documented response are considered non-responders.
Outcome measures
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Response Rate (ORR) as Assessed by Investigator
|
81.4 percentage of participants
Interval 76.8 to 85.5
|
68.5 percentage of participants
Interval 59.0 to 77.0
|
SECONDARY outcome
Timeframe: Final Analysis; median overall follow-up of 58.97 monthsPopulation: ITT Population
Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause. If a participant is not known to have died (this includes participants with unknown death date), OS will be censored at the date the participant was last known to have been alive. Estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 69.72 to
not reached/ not estimable
|
78.98 months
Interval 57.36 to
not reached/ not estimable
|
SECONDARY outcome
Timeframe: Primary Analysis; median overall follow-up of 53.75 monthsPopulation: ITT Population
The infusion-related reactions (IRR) rate is the proportion of subjects experiencing infusion related reactions that start on the day of a rituximab infusion and are assessed as related or possibly related to rituximab.
Outcome measures
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Infusion-related Reaction Rate Assessed by Investigator
|
21.3 percentage of participants
Interval 17.0 to 26.0
|
27.0 percentage of participants
Interval 19.0 to 36.3
|
SECONDARY outcome
Timeframe: Primary Analysis; median overall follow-up of 53.75 monthsPopulation: ITT Population. Participants achieving a response (partial response or better) are included in this analysis. Participants achieving response (partial response or better) who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored.
DOR is defined as the time from initial complete response (CR) or partial response (PR) to progressive disease (PD) or death due to any cause, whichever is first reported, regardless of discontinuation of study treatment. If such event did not occur, then participants were to be censored at the last adequate disease assessment as required for PFS censoring. Estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Arm A: Ibrutinib + Rituximab
n=272 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=76 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Duration of Response (DOR) as Assessed by Investigator
|
44.25 months
Interval 36.63 to
not reached/ not estimable
|
34.56 months
Interval 29.21 to 47.31
|
SECONDARY outcome
Timeframe: Overall median treatment duration of 22.11 monthsPopulation: Safety Population
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The treatment-emergent period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent anti-cancer therapy, whichever comes first. The treatment-emergent adverse events (TEAEs) are those events that occur or worsen during the treatment-emergent period or that are related to the study treatment.
Outcome measures
| Measure |
Arm A: Ibrutinib + Rituximab
n=330 Participants
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 Participants
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Grade ≥3 TEAEs
|
259 Participants
|
63 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious Adverse Events (SAEs)
|
204 Participants
|
45 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Fatal TEAEs
|
48 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Discontinued study drug due to AE
|
144 Participants
|
16 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Most frequent Grade ≥3 TEAE (neutropenia)
|
52 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any Treatment-Emergent Adverse Event (TEAE)
|
324 Participants
|
106 Participants
|
Adverse Events
Arm A: Ibrutinib + Rituximab
Serious events: 214 serious events
Other events: 310 other events
Deaths: 123 deaths
Arm B: Placebo + Rituximab
Serious events: 48 serious events
Other events: 101 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 participants at risk
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 participants at risk
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.2%
4/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
6.3%
21/334 • Number of events 21 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
BRADYCARDIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CARDIAC ARREST
|
1.2%
4/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CARDIAC ASTHMA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.5%
5/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.90%
3/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CHRONIC CORONARY SYNDROME
|
0.30%
1/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
PERICARDITIS
|
0.90%
3/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
TACHYCARDIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Ear and labyrinth disorders
LABYRINTHINE FISTULA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
EPIRETINAL MEMBRANE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
COLITIS
|
0.60%
2/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.8%
6/334 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ENTERITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
GASTROINTESTINAL POLYP HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
NAUSEA
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
OBSTRUCTIVE PANCREATITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
PANCREATOLITHIASIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
VOMITING
|
1.5%
5/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
ASTHENIA
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
CHEST PAIN
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
CHILLS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
DEATH
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.90%
3/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
PYREXIA
|
1.8%
6/334 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
BILIARY OBSTRUCTION
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
HEPATIC CYTOLYSIS
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
ABSCESS LIMB
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
APPENDICITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
BACTERAEMIA
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
BRONCHITIS
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CANDIDA SEPSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CARBUNCLE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CELLULITIS
|
1.8%
6/334 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CENTRAL NERVOUS SYSTEM FUNGAL INFECTION
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CLOSTRIDIUM COLITIS
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
COVID-19
|
7.5%
25/334 • Number of events 31 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
6.3%
21/334 • Number of events 35 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
4.5%
5/111 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CYCLOSPORIDIUM INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
DIABETIC FOOT INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
ENDOCARDITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
ERYSIPELAS
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
GANGRENE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
GASTROENTERITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
GASTROENTERITIS ROTAVIRUS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
HEPATITIS B REACTIVATION
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
INFECTIOUS PLEURAL EFFUSION
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
INFLUENZA
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
MENINGITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PHARYNGITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PNEUMONIA
|
10.8%
36/334 • Number of events 45 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
4.5%
5/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PNEUMONIA ASPIRATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PROSTATITIS ESCHERICHIA COLI
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PROTEUS INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
1.5%
5/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
SEPSIS
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
SEPSIS PASTEURELLA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
SEPTIC SHOCK
|
1.2%
4/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
SPLENIC ABSCESS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
SPONTANEOUS BACTERIAL PERITONITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
STENOTROPHOMONAS INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.60%
2/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
SUPERINFECTION BACTERIAL
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
TONSILLITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
URINARY TRACT CANDIDIASIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.3%
11/334 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
3.6%
4/111 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
URINARY TRACT INFECTION PSEUDOMONAL
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
UROSEPSIS
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
WOUND INFECTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
CRANIOFACIAL FRACTURE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
EXTRA-AXIAL HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
FALL
|
1.2%
4/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
FRACTURE DISPLACEMENT
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.2%
4/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
URETERIC INJURY
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Investigations
OCCULT BLOOD POSITIVE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER RECURRENT
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER FATIGUE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FOLLICULAR LYMPHOMA
|
0.90%
3/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE LOBULAR BREAST CARCINOMA
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC RENAL CELL CARCINOMA
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NASAL CAVITY CANCER
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL NEOPLASM BENIGN
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.90%
3/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER RECURRENT
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA RECURRENT
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SIGNET-RING CELL CARCINOMA
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CANCER OF THE RENAL PELVIS AND URETER
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR NECROSIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
BASAL GANGLIA HAEMORRHAGE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
HAEMORRHAGIC TRANSFORMATION STROKE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
INTRACRANIAL HAEMATOMA
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
1.8%
6/334 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
SCIATICA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
STIFF PERSON SYNDROME
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
SYNCOPE
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.60%
2/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
DELIRIUM
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
DEPRESSION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.8%
6/334 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
DYSURIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
RENAL HAEMATOMA
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
RENAL HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.30%
1/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.30%
1/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Reproductive system and breast disorders
UTERINE MASS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.90%
3/334 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
CHYLOTHORAX
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.2%
4/334 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.60%
2/334 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.5%
5/334 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
2.7%
3/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ACIDOSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.2%
4/334 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
ISCHAEMIC SKIN ULCER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
SKIN DISCHARGE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
EMBOLISM
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
HYPERTENSION
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
NEUROGENIC SHOCK
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
PERIPHERAL VENOUS DISEASE
|
0.30%
1/334 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/334 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
Other adverse events
| Measure |
Arm A: Ibrutinib + Rituximab
n=334 participants at risk
Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Arm B: Placebo + Rituximab
n=111 participants at risk
Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
14.7%
49/334 • Number of events 83 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
8.1%
9/111 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
9.3%
31/334 • Number of events 40 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
20.1%
67/334 • Number of events 118 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
10.8%
12/111 • Number of events 15 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
9.3%
31/334 • Number of events 72 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
10.8%
36/334 • Number of events 39 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
CATARACT
|
7.8%
26/334 • Number of events 30 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
DRY EYE
|
18.0%
60/334 • Number of events 84 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
15.3%
17/111 • Number of events 26 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
EYE IRRITATION
|
12.3%
41/334 • Number of events 56 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
16.2%
18/111 • Number of events 26 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
EYE PAIN
|
6.9%
23/334 • Number of events 27 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
6.3%
7/111 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
LACRIMATION INCREASED
|
12.0%
40/334 • Number of events 58 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
11.7%
13/111 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
PHOTOPHOBIA
|
9.6%
32/334 • Number of events 41 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
6.3%
7/111 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
PHOTOPSIA
|
3.9%
13/334 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
6.3%
7/111 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
VISION BLURRED
|
15.9%
53/334 • Number of events 74 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
9.0%
10/111 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
11.7%
39/334 • Number of events 55 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
15.3%
17/111 • Number of events 27 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Eye disorders
VITREOUS FLOATERS
|
7.8%
26/334 • Number of events 34 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
10.8%
12/111 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.6%
32/334 • Number of events 42 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.1%
27/334 • Number of events 31 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
8.1%
9/111 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.9%
53/334 • Number of events 65 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
14.4%
16/111 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
DIARRHOEA
|
34.7%
116/334 • Number of events 205 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
13.5%
15/111 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.8%
16/334 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
6.3%
7/111 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
NAUSEA
|
20.7%
69/334 • Number of events 92 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
10.8%
12/111 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
STOMATITIS
|
7.8%
26/334 • Number of events 41 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Gastrointestinal disorders
VOMITING
|
12.3%
41/334 • Number of events 62 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
4.5%
5/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
ASTHENIA
|
10.5%
35/334 • Number of events 44 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
6.3%
7/111 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
CHILLS
|
3.6%
12/334 • Number of events 15 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
7.2%
8/111 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
FATIGUE
|
21.6%
72/334 • Number of events 120 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
14.4%
16/111 • Number of events 25 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
OEDEMA PERIPHERAL
|
18.9%
63/334 • Number of events 95 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
16.2%
18/111 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
General disorders
PYREXIA
|
10.5%
35/334 • Number of events 42 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
13.5%
15/111 • Number of events 21 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
BRONCHITIS
|
6.9%
23/334 • Number of events 27 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
3.6%
4/111 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
CONJUNCTIVITIS
|
6.3%
21/334 • Number of events 25 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
4.5%
5/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
COVID-19
|
18.6%
62/334 • Number of events 74 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
19.8%
22/111 • Number of events 26 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.2%
14/334 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
PNEUMONIA
|
6.0%
20/334 • Number of events 24 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
3.6%
4/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.1%
27/334 • Number of events 41 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
18.0%
60/334 • Number of events 122 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
9.0%
10/111 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
FALL
|
9.9%
33/334 • Number of events 36 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
9.9%
11/111 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
8.1%
27/334 • Number of events 31 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
14.4%
16/111 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Investigations
WEIGHT DECREASED
|
5.1%
17/334 • Number of events 21 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
3.6%
4/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
10.2%
34/334 • Number of events 36 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
3.6%
4/111 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
8.1%
27/334 • Number of events 35 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.5%
35/334 • Number of events 54 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
2.7%
3/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.9%
63/334 • Number of events 83 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
14.4%
16/111 • Number of events 24 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
13.5%
45/334 • Number of events 54 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
13.5%
15/111 • Number of events 15 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
11.7%
39/334 • Number of events 52 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
7.2%
8/111 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.6%
22/334 • Number of events 26 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
9.0%
30/334 • Number of events 33 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
DIZZINESS
|
9.6%
32/334 • Number of events 37 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
4.5%
5/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Nervous system disorders
HEADACHE
|
13.5%
45/334 • Number of events 71 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
4.5%
5/111 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Psychiatric disorders
INSOMNIA
|
8.1%
27/334 • Number of events 28 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
10.8%
12/111 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.1%
57/334 • Number of events 72 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
15.3%
17/111 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.4%
38/334 • Number of events 45 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
18.0%
20/111 • Number of events 29 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
7.2%
24/334 • Number of events 31 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
2.7%
3/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
1.2%
4/334 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.0%
20/334 • Number of events 20 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
2.7%
3/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.1%
17/334 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
1.8%
2/111 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
5.1%
17/334 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.00%
0/111 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.8%
26/334 • Number of events 36 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
11.7%
13/111 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
6.6%
22/334 • Number of events 31 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
0.90%
1/111 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
9.3%
31/334 • Number of events 45 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
3.6%
4/111 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
HYPERTENSION
|
14.4%
48/334 • Number of events 76 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
9.0%
10/111 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
|
Vascular disorders
HYPOTENSION
|
2.7%
9/334 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
5.4%
6/111 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER