Trial Outcomes & Findings for A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (NCT NCT05564052)
NCT ID: NCT05564052
Last Updated: 2025-10-07
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure.
COMPLETED
PHASE2
36 participants
From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
2025-10-07
Participant Flow
The study was planned to be conducted in 2 parts: Phase 2 and Phase 3. However, due to early termination of enrollment, no participants were enrolled on the Phase 3 part of the study. Hence, the results were only presented for Phase 2 part. Participants with relapsed or refractory mantle cell lymphoma were enrolled in the study.
Participant milestones
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
8
|
9
|
|
Overall Study
Participants Who Switched to Ibrutinib Monotherapy
|
0
|
4
|
3
|
2
|
|
Overall Study
COMPLETED
|
10
|
9
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 Participants
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
68.9 Years
STANDARD_DEVIATION 8.08 • n=7 Participants
|
64.6 Years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 7.60 • n=4 Participants
|
66.2 Years
STANDARD_DEVIATION 8.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
BRAZIL
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
GREECE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
MALAYSIA
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
POLAND
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
SPAIN
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
TAIWAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
THAILAND
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
TURKEY
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)Population: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 Participants
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B
Discontinuation of Treatment Rituximab
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B
Discontinuation of Treatment Ibrutinib/Lenalidomide
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)Population: Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs included serious and non-serious events were reported in this outcome measure.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)Population: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 Participants
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Arms A1, A2, A3 and B
|
7 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)Population: Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Monotherapy Arm
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)Population: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 Participants
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and B
|
4 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)Population: Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)Population: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Here, 'n' (number analyzed) signifies the participants analyzed for each specified parameter and n=0 signifies that there was no evaluable participant for specified parameter.
Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 Participants
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Platelet Count Decreased Grade 1
|
4 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Neutrophil Count Decreased Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Neutrophil Count Decreased Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Neutrophil Count Decreased Grade 3
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Neutrophil Count Decreased Grade 4
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Platelet Count Decreased Grade 0
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Platelet Count Decreased Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Platelet Count Decreased Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Platelet Count Decreased Grade 4
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Prothrombin INR Increased Grade 0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Decreased Grade 0
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Decreased Grade 1
|
5 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Decreased Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Decreased Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Decreased Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Increased Grade 0
|
10 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
WBC Increased Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
aPTT Prolonged Grade 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Hemoglobin Decreased Grade 0
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Hemoglobin Decreased Grade 1
|
3 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Hemoglobin Decreased Grade 2
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Hemoglobin Decreased Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Hemoglobin Increased Grade 0
|
10 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Decreased Grade 0
|
4 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Decreased Grade 1
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Decreased Grade 2
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Decreased Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Decreased Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Increased Grade 0
|
8 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Increased Grade 2
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Lymphocyte Count Increased Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
Neutrophil Count Decreased Grade 0
|
4 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)Population: Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants analyzed for each specified parameter.
Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
aPTT Prolonged Grade 0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Hemoglobin Decreased Grade 0
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Hemoglobin Decreased Grade 1
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Hemoglobin Decreased Grade 2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Lymphocyte Count Decreased Grade 0
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Lymphocyte Count Decreased Grade 2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Lymphocyte Count Decreased Grade 4
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Lymphocyte Count Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Neutrophil Count Decreased Grade 0
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Neutrophil Count Decreased Grade 2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Platelet Count Decreased Grade 1
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
WBC Decreased Grade 1
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
WBC Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Hemoglobin Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Lymphocyte Count Decreased Grade 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Platelet Count Decreased Grade 0
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Prothrombin INR Increased Grade 0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
WBC Decreased Grade 0
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
Neutrophil Count Decreased Grade 1
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)Population: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.
Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin (BL), alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 Participants
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 Participants
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
ALT Increased Grade 0
|
5 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
ALT Increased Grade 1
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
ALT Increased Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Albumin Decreased Grade 0
|
6 Participants
|
9 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Albumin Decreased Grade 1
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Albumin Decreased Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Alkaline Phosphatase (AP) Increased Grade 0
|
8 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
AP Increased Grade 1
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
AST Increased Grade 0
|
5 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
AST Increased Grade 1
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
AST Increased Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Bilirubin (BL) Increased Grade 0
|
7 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
BL Increased Grade 1
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
BL Increased Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
BL Increased Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Calcium Corrected Decreased Grade 0
|
7 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Calcium Corrected Decreased Grade 1
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Creatinine Increased Grade 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Potassium Decreased Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Sodium Increased Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Potassium Decreased Grade 0
|
7 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Calcium Corrected Decreased Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Calcium Corrected Increased Grade 0
|
10 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Calcium Corrected Increased Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Creatinine Increased Grade 0
|
9 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Creatinine Increased Grade 1
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Potassium Decreased Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Sodium Decreased Grade 1
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Sodium Increased Grade 0
|
8 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Potassium Increased Grade 0
|
10 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Potassium Increased Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
Sodium Decreased Grade 0
|
7 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)Population: Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants analyzed for each specified parameter.
Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin, alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=8 Participants
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
ALT Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Albumin Decreased Grade 0
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Albumin Decreased Grade 1
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Alkaline Phosphatase Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
AST Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Bilirubin Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Calcium Corrected Decreased Grade 0
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Calcium Corrected Decreased Grade 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Calcium Corrected Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Creatinine Increased Grade 0
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Creatinine Increased Grade 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Potassium Decreased Grade 0
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Potassium Decreased Grade 2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Potassium Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Sodium Decreased Grade 0
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Sodium Decreased Grade 1
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
Sodium Increased Grade 0
|
8 Participants
|
—
|
—
|
—
|
Adverse Events
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
Monotherapy Arm: Ibrutinib 560 mg
Serious adverse events
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 participants at risk
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 participants at risk
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 participants at risk
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 participants at risk
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Monotherapy Arm: Ibrutinib 560 mg
n=9 participants at risk
Participants from Arm A2 (Ibrutinib 420 mg QD + Rituximab), Arm A3 (Ibrutinib 140 mg BID + Rituximab) and Arm B (Lenalidomide 20 mg + Rituximab) who were earlier receiving ibrutinib/lenalidomide + rituximab later switched to ibrutinib monotherapy post protocol amendment 1 (dated 08 June 2023), received ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
22.2%
2/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Enterocolitis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Hepatic Enzyme Increased
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Metastatic
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Nervous system disorders
Cerebellar Haemorrhage
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Vascular disorders
Hypertensive Crisis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
Other adverse events
| Measure |
Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2
n=10 participants at risk
Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m\^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2
n=9 participants at risk
Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2
n=8 participants at risk
Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2
n=9 participants at risk
Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance \[CrCl\] was 30 to less than \[\<\] 60 milliliters per minute \[mL/min\]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
Monotherapy Arm: Ibrutinib 560 mg
n=9 participants at risk
Participants from Arm A2 (Ibrutinib 420 mg QD + Rituximab), Arm A3 (Ibrutinib 140 mg BID + Rituximab) and Arm B (Lenalidomide 20 mg + Rituximab) who were earlier receiving ibrutinib/lenalidomide + rituximab later switched to ibrutinib monotherapy post protocol amendment 1 (dated 08 June 2023), received ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
33.3%
3/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
4/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
50.0%
4/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
44.4%
4/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
33.3%
3/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Eye disorders
Conjunctivitis Allergic
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
25.0%
2/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
37.5%
3/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Extravasation
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Infusion Site Rash
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Oedema Peripheral
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Puncture Site Haematoma
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Body Tinea
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Conjunctivitis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Covid-19
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Folliculitis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Fungal Foot Infection
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Herpes Zoster
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
22.2%
2/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Respiratory Tract Infection
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Rhinitis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Soft Tissue Infection
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
20.0%
2/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
25.0%
2/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Blood Immunoglobulin M Decreased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Blood Lactate Dehydrogenase Decreased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Hepatic Enzyme Increased
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
25.0%
2/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
22.2%
2/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Platelet Count Increased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
Weight Decreased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
2/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
2/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma Benign
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Nervous system disorders
Ischaemic Stroke
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic Cyst
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Discomfort
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Nail Bed Inflammation
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
12.5%
1/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Vascular disorders
Aortic Dilatation
|
0.00%
0/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
|
Vascular disorders
Hypertension
|
50.0%
5/10 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
11.1%
1/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/8 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
0.00%
0/9 • Arm A1, A2, A3 and B: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months); Monotherapy arm: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
|
Additional Information
Sr. Director Clinical Sciences Onc
Janssen Research & Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER