Trial Outcomes & Findings for Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01724346)
NCT ID: NCT01724346
Last Updated: 2024-09-19
Results Overview
PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
Median overall follow-up of 82.7 months
Results posted on
2024-09-19
Participant Flow
This extension study provided ongoing treatment and follow-up for participants previously enrolled in the parent study (PCYC-1115-CA; Study 1115; NCT01722487). Participants entered this study upon Independent Review Committee (IRC)-confirmed progressive disease (PD) or the closure of Study 1115, whichever was earlier.
All participants randomized to chlorambucil in Study 1115 completed or discontinued their first-line treatment prior to rollover. Participants randomized to ibrutinib in Study 1115 with no PD could continue their first-line treatment in this study. Next-line treatment with ibrutinib after PD was a subsequent-therapy option for participants enrolled in the chlorambucil arm only.
Participant milestones
| Measure |
Ibrutinib
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to receive next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
133
|
|
Overall Study
Received Next-Line Ibrutinib After PD
|
0
|
78
|
|
Overall Study
COMPLETED
|
57
|
63
|
|
Overall Study
NOT COMPLETED
|
79
|
70
|
Reasons for withdrawal
| Measure |
Ibrutinib
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to receive next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Overall Study
Death
|
42
|
42
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
27
|
19
|
|
Overall Study
Did Not Rollover From Parent Study
|
5
|
8
|
Baseline Characteristics
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 5.67 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 5.95 • n=7 Participants
|
73.3 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
132 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
120 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Subject declined to answer/unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: Intent-to-Treat (ITT) Population: All randomized participants in Study 1115.
PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Progression Free Survival (PFS) Based on Investigator Assessment
|
106.9 months
Interval 83.4 to
Not estimable because there were not enough PFS events to get a reliable upper bound of 95% confidence interval (CI).
|
15.0 months
Interval 10.2 to 19.4
|
SECONDARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: ITT Population: All randomized participants in Study 1115.
PFS2 is defined as the time from the date of randomization to the earliest occurrence of the following three types of events: * PD per investigator response assessment after initiation of the first subsequent anti-cancer therapy * Initiation of second subsequent anti-cancer therapy * Death due to any cause, regardless of administration of subsequent anticancer therapy. Kaplan-Meier landmark estimate of the PFS2 rate at 60 months (that is, the estimated percentage of participants with PFS2 at Month 60) is presented.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)
|
79.3 percentage of participants
Interval 71.1 to 85.4
|
58.4 percentage of participants
Interval 48.8 to 66.7
|
SECONDARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: ITT Population: All randomized participants in Study 1115.
OS is defined as the time from randomization to death due to any cause. Kaplan-Meier landmark estimate of the OS rate at 60 months (that is, the estimated percentage of participants with OS at Month 60) is presented.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Overall Survival (OS)
|
82.8 percentage of participants
Interval 75.0 to 88.3
|
68.4 percentage of participants
Interval 59.1 to 75.9
|
SECONDARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: ITT Population: All randomized participants in Study 1115.
Time from randomization to initiation of any subsequent treatment for chronic lymphocytic leukemia (CLL).
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Time to Next Treatment (TTNT)
|
NA months
Not estimable because there were not enough TTNT events.
|
25.1 months
Interval 21.8 to 27.9
|
SECONDARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: ITT Population: All randomized participants in Study 1115.
ORR is defined as the percentage of participants who achieve complete response (CR), complete response with an incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR), as determined by the investigator at or prior to initiation of subsequent antineoplastic therapy according to the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
91.2 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: ITT Population: All randomized participants in Study 1115.
Percentage of participants who achieved MRD-negative response defined as \< 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate and/or peripheral blood sample per central laboratory at or prior to initiation of subsequent antineoplastic therapy.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=133 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Rate of Minimal Residual Disease (MRD) Negativity
|
5.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Median overall follow-up of 82.7 monthsPopulation: ITT Participants Achieving Response (Partial Response or Better) per protocol definitions (Halleck 2008).
DOR will be calculated for the participants achieving a protocol-defined response (Halleck 2008; CR, CRi, nPR, PR) per investigator assessment and is defined as time from the date of initial response including PR with lymphocytosis to the date of disease progression or the date of death from any cause, whichever occurs first.
Outcome measures
| Measure |
Ibrutinib
n=124 Participants
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=49 Participants
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 84.0 to
Not estimable because there were not enough DOR events.
|
29.7 months
Interval 15.2 to 40.4
|
Adverse Events
Ibrutinib
Serious events: 111 serious events
Other events: 134 other events
Deaths: 42 deaths
Chlorambucil
Serious events: 33 serious events
Other events: 120 other events
Deaths: 44 deaths
Next-line Ibrutinib After PD on Chlorambucil
Serious events: 49 serious events
Other events: 75 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Ibrutinib
n=135 participants at risk
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=132 participants at risk
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115.
|
Next-line Ibrutinib After PD on Chlorambucil
n=78 participants at risk
Participants who received chlorambucil treatment in Study 1115 and crossed over to next-line ibrutinib 420 mg/day in Study 1116.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
AUTOIMMUNE HAEMOLYTIC ANAEMIA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.0%
4/135 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
AORTIC VALVE DISEASE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
AORTIC VALVE DISEASE MIXED
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ARRHYTHMIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
8.1%
11/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ATRIAL FLUTTER
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIAC ARREST
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIAC DYSFUNCTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIAC FAILURE
|
3.7%
5/135 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
PALPITATIONS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
SINUS NODE DYSFUNCTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Congenital, familial and genetic disorders
THYROGLOSSAL CYST
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Ear and labyrinth disorders
VERTIGO
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
BLINDNESS UNILATERAL
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
CATARACT
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
EYE OEDEMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
GLAUCOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
RETINAL DETACHMENT
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
RETINAL VASCULAR OCCLUSION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
GASTRITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
OVERFLOW DIARRHOEA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
1.5%
2/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
STOMATITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
VOMITING
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
CHEST PAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
CHILLS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
DEATH
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
FATIGUE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
OEDEMA PERIPHERAL
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
PAIN
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
PHYSICAL DECONDITIONING
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
PYREXIA
|
3.0%
4/135 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
SUDDEN DEATH
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
CHOLANGITIS
|
2.2%
3/135 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
HEPATITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
HEPATITIS TOXIC
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Immune system disorders
IMMUNODEFICIENCY
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ABSCESS LIMB
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ACUTE HEPATITIS B
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ANAL ABSCESS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
BACTERAEMIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
BILIARY SEPSIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
BRONCHITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
COVID-19
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
3.0%
4/135 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CANDIDA SEPSIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CELLULITIS
|
2.2%
3/135 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CHOLANGITIS INFECTIVE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.74%
1/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
1.5%
2/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CORONAVIRUS INFECTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ERYSIPELAS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
GASTROENTERITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
INFLUENZA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
KLEBSIELLA INFECTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
3.0%
4/135 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
ORCHITIS
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
OSTEOMYELITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMOCOCCAL SEPSIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA
|
20.0%
27/135 • Number of events 38 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.0%
7/78 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA LEGIONELLA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA PSEUDOMONAL
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
POST PROCEDURAL PNEUMONIA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PSEUDOMONAL BACTERAEMIA
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
SEPSIS
|
3.7%
5/135 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
SEPTIC SHOCK
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.4%
6/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
UROSEPSIS
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
VIRAL INFECTION
|
1.5%
2/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
WOUND INFECTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
FALL
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
FRACTURED SACRUM
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
HEAT STROKE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
HYPHAEMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
LIMB TRAUMATIC AMPUTATION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE WOUND COMPLICATION
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SHOULDER FRACTURE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SUBCUTANEOUS HAEMATOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
URINARY RETENTION POSTOPERATIVE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
FIBRIN D DIMER INCREASED
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
HEART RATE IRREGULAR
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
3.7%
5/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.74%
1/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
HAEMATOMA MUSCLE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
6.7%
9/135 • Number of events 12 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASOSQUAMOUS CARCINOMA OF SKIN
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL ADENOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
1.5%
2/135 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MUCINOUS ADENOCARCINOMA OF APPENDIX
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER METASTATIC
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
3.0%
4/135 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RICHTER'S SYNDROME
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SPINDLE CELL SARCOMA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
CAUDA EQUINA SYNDROME
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
COGNITIVE DISORDER
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
DEMENTIA
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
DEMENTIA ALZHEIMER'S TYPE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
DYSARTHRIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
EPILEPSY
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
HEADACHE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
HEMIANOPIA HOMONYMOUS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
POST HERPETIC NEURALGIA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
SEIZURE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
SYNCOPE
|
3.7%
5/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
3.7%
5/135 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Product Issues
DEVICE OCCLUSION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
CARDIOVASCULAR SOMATIC SYMPTOM DISORDER
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
DELIRIUM
|
2.2%
3/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
3.0%
4/135 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
BLADDER CYST
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
BLADDER TAMPONADE
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
HAEMATURIA
|
3.0%
4/135 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
RENAL HAEMORRHAGE
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Reproductive system and breast disorders
PERINEAL FISTULA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.74%
1/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
HYPERCAPNIA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.7%
5/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOMEDIASTINUM
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERIAL HYPERTENSION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
1.5%
2/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.74%
1/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.74%
1/135 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.74%
1/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
0.74%
1/135 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
HYPERTENSION
|
3.0%
4/135 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/135 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
Other adverse events
| Measure |
Ibrutinib
n=135 participants at risk
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
|
Chlorambucil
n=132 participants at risk
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115.
|
Next-line Ibrutinib After PD on Chlorambucil
n=78 participants at risk
Participants who received chlorambucil treatment in Study 1115 and crossed over to next-line ibrutinib 420 mg/day in Study 1116.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
24.4%
33/135 • Number of events 86 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
18.9%
25/132 • Number of events 53 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
17.9%
14/78 • Number of events 29 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
16.3%
22/135 • Number of events 29 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
10.3%
8/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
4.4%
6/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
17.8%
24/135 • Number of events 43 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
21.2%
28/132 • Number of events 50 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.0%
7/78 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
SPONTANEOUS HAEMATOMA
|
5.2%
7/135 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
14.8%
20/135 • Number of events 49 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.9%
17/132 • Number of events 29 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
10.3%
8/78 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
15.6%
21/135 • Number of events 23 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Cardiac disorders
PALPITATIONS
|
8.1%
11/135 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
CATARACT
|
16.3%
22/135 • Number of events 27 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
10.4%
14/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
DRY EYE
|
20.0%
27/135 • Number of events 40 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
EYE IRRITATION
|
9.6%
13/135 • Number of events 23 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
EYE PAIN
|
7.4%
10/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
LACRIMATION INCREASED
|
14.8%
20/135 • Number of events 47 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.1%
8/132 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
PHOTOPHOBIA
|
5.9%
8/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
VISION BLURRED
|
17.0%
23/135 • Number of events 33 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
8.3%
11/132 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
10.3%
8/78 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
12.6%
17/135 • Number of events 24 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Eye disorders
VITREOUS FLOATERS
|
9.6%
13/135 • Number of events 19 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.3%
7/132 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.3%
22/135 • Number of events 30 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.8%
13/132 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.4%
10/135 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
5.2%
7/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.2%
30/135 • Number of events 48 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
15.9%
21/132 • Number of events 21 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
15.4%
12/78 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
DIARRHOEA
|
49.6%
67/135 • Number of events 145 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
16.7%
22/132 • Number of events 33 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
34.6%
27/78 • Number of events 60 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
15.6%
21/135 • Number of events 26 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
14.1%
11/78 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
12.6%
17/135 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
5.9%
8/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
6.7%
9/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
NAUSEA
|
31.9%
43/135 • Number of events 60 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
39.4%
52/132 • Number of events 75 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
16.7%
13/78 • Number of events 22 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
STOMATITIS
|
9.6%
13/135 • Number of events 22 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Gastrointestinal disorders
VOMITING
|
21.5%
29/135 • Number of events 37 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
20.5%
27/132 • Number of events 42 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.8%
10/78 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
ASTHENIA
|
12.6%
17/135 • Number of events 20 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
11.5%
9/78 • Number of events 12 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
CHEST PAIN
|
7.4%
10/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
FATIGUE
|
40.7%
55/135 • Number of events 110 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
38.6%
51/132 • Number of events 85 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
23.1%
18/78 • Number of events 35 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
OEDEMA PERIPHERAL
|
28.9%
39/135 • Number of events 71 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
8.3%
11/132 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
19.2%
15/78 • Number of events 21 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
PAIN
|
5.2%
7/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
PERIPHERAL SWELLING
|
5.2%
7/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
General disorders
PYREXIA
|
26.7%
36/135 • Number of events 59 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
10.6%
14/132 • Number of events 23 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
11.5%
9/78 • Number of events 20 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
5.2%
7/135 • Number of events 24 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
BRONCHITIS
|
12.6%
17/135 • Number of events 34 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.0%
4/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
COVID-19
|
11.1%
15/135 • Number of events 18 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CELLULITIS
|
9.6%
13/135 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CONJUNCTIVITIS
|
16.3%
22/135 • Number of events 37 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
10.3%
8/78 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
CYSTITIS
|
5.2%
7/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
EYE INFECTION
|
5.9%
8/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
FOLLICULITIS
|
5.2%
7/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
HERPES ZOSTER
|
9.6%
13/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.3%
7/132 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
INFLUENZA
|
5.2%
7/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.0%
4/132 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.0%
7/78 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.1%
15/135 • Number of events 27 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PHARYNGITIS
|
5.9%
8/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
PNEUMONIA
|
8.9%
12/135 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
4.4%
6/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
RHINITIS
|
5.2%
7/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
SINUSITIS
|
6.7%
9/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
SKIN INFECTION
|
9.6%
13/135 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
28.1%
38/135 • Number of events 73 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
17.4%
23/132 • Number of events 30 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
25.6%
20/78 • Number of events 31 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
21.5%
29/135 • Number of events 87 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.6%
10/132 • Number of events 15 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.8%
10/78 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
CONTUSION
|
19.3%
26/135 • Number of events 40 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
FALL
|
18.5%
25/135 • Number of events 45 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
11.5%
9/78 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
5.9%
8/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
6.7%
9/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
3.7%
5/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.0%
4/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
4.4%
6/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
BLOOD CREATININE INCREASED
|
8.1%
11/135 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
PLATELET COUNT DECREASED
|
5.2%
7/135 • Number of events 62 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Investigations
WEIGHT DECREASED
|
25.2%
34/135 • Number of events 47 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.1%
16/132 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
15.4%
12/78 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
17.8%
24/135 • Number of events 38 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
14.4%
19/132 • Number of events 26 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.0%
7/78 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
17.0%
23/135 • Number of events 37 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
5.2%
7/135 • Number of events 25 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.9%
16/135 • Number of events 26 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.2%
7/135 • Number of events 15 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
8.9%
12/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
30.4%
41/135 • Number of events 75 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.6%
10/132 • Number of events 18 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
28.2%
22/78 • Number of events 40 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.0%
27/135 • Number of events 38 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.8%
9/132 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.8%
10/78 • Number of events 12 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
5.2%
7/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
20.7%
28/135 • Number of events 40 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.3%
7/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
16.7%
13/78 • Number of events 20 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
6.7%
9/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.1%
11/135 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.0%
4/132 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.9%
8/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.0%
4/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
5.9%
8/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
17.0%
23/135 • Number of events 27 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.3%
7/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
10.3%
8/78 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
10.4%
14/135 • Number of events 22 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
5.2%
7/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
5.9%
8/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.3%
1/78 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
DIZZINESS
|
18.5%
25/135 • Number of events 29 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.1%
16/132 • Number of events 22 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.8%
10/78 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
HEADACHE
|
14.1%
19/135 • Number of events 32 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.8%
13/132 • Number of events 23 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
11.5%
9/78 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.2%
7/135 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
PARAESTHESIA
|
5.2%
7/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Nervous system disorders
SYNCOPE
|
5.2%
7/135 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
ANXIETY
|
11.9%
16/135 • Number of events 21 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
DEPRESSION
|
8.1%
11/135 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.0%
7/78 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Psychiatric disorders
INSOMNIA
|
13.3%
18/135 • Number of events 22 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.8%
9/132 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 11 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
6.7%
9/135 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
5.9%
8/135 • Number of events 12 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
HAEMATURIA
|
9.6%
13/135 • Number of events 14 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Renal and urinary disorders
POLLAKIURIA
|
5.9%
8/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.0%
4/132 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/78 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
38.5%
52/135 • Number of events 79 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
15.2%
20/132 • Number of events 24 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
24.4%
19/78 • Number of events 25 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
15.6%
21/135 • Number of events 37 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.8%
13/132 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
14.1%
11/78 • Number of events 20 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.9%
8/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
15.6%
21/135 • Number of events 26 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
9.0%
7/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.9%
8/135 • Number of events 9 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
11.9%
16/135 • Number of events 23 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
8.1%
11/135 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
5.9%
8/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
8.9%
12/135 • Number of events 19 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
1.5%
2/132 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
1.5%
2/135 • Number of events 2 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.9%
12/135 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
2.2%
3/135 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
11.5%
9/78 • Number of events 12 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
10.4%
14/135 • Number of events 16 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.6%
10/132 • Number of events 12 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
5.2%
7/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.1%
19/135 • Number of events 29 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.3%
7/132 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
6.4%
5/78 • Number of events 10 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
5.2%
7/135 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.6%
2/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.7%
9/135 • Number of events 22 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
2.3%
3/132 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
3/78 • Number of events 3 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
12.6%
17/135 • Number of events 30 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 4 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
9.6%
13/135 • Number of events 19 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
3.8%
5/132 • Number of events 7 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
7.7%
6/78 • Number of events 17 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
8.1%
11/135 • Number of events 13 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.76%
1/132 • Number of events 1 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 5 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
HYPERTENSION
|
27.4%
37/135 • Number of events 64 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
0.00%
0/132 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
12.8%
10/78 • Number of events 26 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
|
Vascular disorders
HYPOTENSION
|
4.4%
6/135 • Number of events 6 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
4.5%
6/132 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
|
5.1%
4/78 • Number of events 8 • All-cause mortality: median overall follow-up of 82.7 months. Adverse events: from first dose of any study treatment to 30 days after last dose of study treatment or initiation of subsequent therapy whichever was earlier. Median treatment duration was: 74.0 months for Ibrutinib arm; 7.1 months for Chlorambucil arm; 26.9 months for Crossover Next-line Ibrutinib arm.
Safety Population: participants in the ITT population who received \>= 1 dose of either chlorambucil or ibrutinib as the first-line therapy in the parent Study 1115. The crossover analysis set used for next-line ibrutinib treatment included all chlorambucil arm participants who received at least 1 dose of ibrutinib as the next-line study treatment. (Two participants in the Chlorambucil arm died after exiting the study, and are reported here but are not reflected in the Participant Flow table.)
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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