Trial Outcomes & Findings for Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (NCT NCT04666038)
NCT ID: NCT04666038
Last Updated: 2025-04-20
Results Overview
PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)
Results posted on
2025-04-20
Participant Flow
A total of 238 participants were randomized 1:1 to receive either Arm A - pirtobrutinib or Arm B - Idelalisib plus Rituximab or Bendamustine plus Rituximab. The results were reported based on a data cut off from 29 Aug 2024.
Participant milestones
| Measure |
Arm A - Pirtobrutinib
Participants received 200 milligrams (mg) of pirtobrutinib administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
Participants received either 150 mg of idelalisib administered twice-daily (BID) orally on Days 1 through 28 of a 28-day cycle in combination with 375 milligram per square meter (mg/m\^2) of rituximab by intravenous (IV) infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 every 2 weeks (Q2W) and 3 IV infusions of rituximab 500 mg/m\^2 every 4 weeks (Q4W) or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
119
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
116
|
109
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
119
|
119
|
Reasons for withdrawal
| Measure |
Arm A - Pirtobrutinib
Participants received 200 milligrams (mg) of pirtobrutinib administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
Participants received either 150 mg of idelalisib administered twice-daily (BID) orally on Days 1 through 28 of a 28-day cycle in combination with 375 milligram per square meter (mg/m\^2) of rituximab by intravenous (IV) infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 every 2 weeks (Q2W) and 3 IV infusions of rituximab 500 mg/m\^2 every 4 weeks (Q4W) or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
2
|
0
|
|
Overall Study
Death
|
38
|
32
|
|
Overall Study
Withdrawal by Subject
|
10
|
19
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
On Study Treatment
|
46
|
5
|
|
Overall Study
Off treatment on post-treatment-discontinuation follow-up
|
23
|
61
|
Baseline Characteristics
Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Baseline characteristics by cohort
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.90 years
STANDARD_DEVIATION 9.32 • n=93 Participants
|
67.00 years
STANDARD_DEVIATION 8.52 • n=4 Participants
|
67.00 years
STANDARD_DEVIATION 8.91 • n=27 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
215 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=93 Participants
|
2 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=93 Participants
|
6 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
China
|
10 participants
n=93 Participants
|
14 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Region of Enrollment
Croatia
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
France
|
5 participants
n=93 Participants
|
4 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
23 participants
n=93 Participants
|
19 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
14 participants
n=93 Participants
|
17 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=93 Participants
|
6 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
33 participants
n=4 Participants
|
53 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
|
13.96 Months
Interval 11.24 to 16.56
|
8.74 Months
Interval 8.08 to 10.38
|
SECONDARY outcome
Timeframe: Randomization to Disease Progression or Death Due to Any Cause (Up to 36 Months)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
PFS is defined as time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an investigator according to iwCLL 2018.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
PFS Assessed by Investigator
|
15.28 Months
Interval 12.81 to 19.94
|
9.20 Months
Interval 7.33 to 10.64
|
SECONDARY outcome
Timeframe: Randomization to Death from Any Cause (Up to 36 months)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
OS was defined as time from randomization to death due to any cause.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Overall Survival (OS)
|
29.67 Months
Interval 27.1 to
Median estimate is unstable due to few patients at risk at later time points. Upper limit of 95% CI was not estimable due to low number of participants with events (events = 38).
|
NA Months
Interval 28.88 to
Median and upper limit of 95% CI was not estimable due to low number of participants with events (events = 32).
|
SECONDARY outcome
Timeframe: Randomization to Subsequent Anticancer Therapy, Therapy of Pirtobrutinib or Death Due to Any Cause (Up to 36 Months)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
TTNT was defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), therapy of pirtobrutinib for Arm B patients, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Time to Next Treatment (TTNT)
|
23.95 Months
Interval 17.84 to 29.67
|
10.91 Months
Interval 8.74 to 12.48
|
SECONDARY outcome
Timeframe: Randomization to Disease Progression, Subsequent Anticancer Therapy, Unacceptable Toxicity Leading to Treatment Discontinuation, or Death Due to Any Cause (Up to 36 Months)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
EFS is defined as the time from randomization to the first occurrence of: * Documented disease progression per iwCLL 2018 criteria as assessed by Investigator; or * Initiation of subsequent anticancer therapy for CLL/SLL; or * Unacceptable toxicity leading to treatment discontinuation as assessed by the Investigator; or * Death (due to any cause).
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Event Free Survival (EFS)
|
14.06 Months
Interval 11.4 to 16.95
|
7.62 Months
Interval 4.8 to 8.8
|
SECONDARY outcome
Timeframe: Randomization to Subsequent Anticancer Therapy, Disease Progression or Death Due to Any Cause (Up to 36 Months)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
ORR according to investigator-assessed best overall response (BOR) based on iwCLL 2018 is defined as the number of participants who achieve a BOR of complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) at or before the initiation of subsequent anticancer therapy divided by the total number of participants randomized to each treatment arm.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=119 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=119 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Percentage of Participants With Overall Response Rate (ORR) Assessed by Investigator
|
66.4 percentage of participants
Interval 57.15 to 74.78
|
48.7 percentage of participants
Interval 39.47 to 58.07
|
SECONDARY outcome
Timeframe: Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome.
TTW was defined as a change in score greater than the meaningful within-person change for worsening in score. Scores were furthermore required to be sustained. To meet the requirement for sustained change, the assessment following the first observation of a meaningful worsening of the score (event date) was also required to show a meaningful worsening compared to baseline. The event date was defined as the first of these consecutive events. The European Organization for Research and Treatment of Cancer Item Library 87 was used, which is scored from 0-100, with higher scores reflecting more symptoms. The time to sustained patient-reported outcome (PRO) deterioration was calculated using all on-treatment assessment time points up to the Week 25 (Arm A \& Arm B - Idelalisib plus Rituximab) and up to Week 21 + Safety follow-up of up to 5 weeks (Arm B - Bendamustine plus Rituximab) assessment time point prior to disease progression.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=110 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=90 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Time to Worsening (TTW) of CLL/SLL Related Symptoms
|
NA Months
Median and 95% CI was not estimable due to low number of events (events = 17).
|
NA Months
Interval 5.7 to
Median and upper limit of 95% CI was not estimable due to low number of events (events = 11).
|
SECONDARY outcome
Timeframe: Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome.
Time of worsening was defined as a change in score greater than the meaningful within-person change for worsening in score. Scores were furthermore required to be sustained. To meet the requirement for sustained change, the assessment following the first observation of a meaningful worsening of the score (event date) was also required to show a meaningful worsening compared to baseline. The event date was defined as the first of these consecutive events. The European Organization for Research and Treatment of Cancer Item Library 87 was used, which is scored from 0-100, with higher scores reflecting more symptoms. The time to sustained PRO deterioration was calculated using all on-treatment assessment time points up to the Week 25 (Arm A and IdelaR) and up to Week 21 + Safety follow-up (BR) assessment time point prior to disease progression.
Outcome measures
| Measure |
Arm A - Pirtobrutinib
n=110 Participants
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=90 Participants
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Time to Worsening (TTW) of Physical Function
|
NA Months
Median and 95% CI was not estimable due to low number of events (events = 12).
|
NA Months
Interval 5.7 to
Median and upper limit of 95% CI was not estimable due to low number of events (events = 11).
|
Adverse Events
Arm A - Pirtobrutinib
Serious events: 60 serious events
Other events: 94 other events
Deaths: 38 deaths
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
Serious events: 53 serious events
Other events: 103 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Arm A - Pirtobrutinib
n=116 participants at risk
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=109 participants at risk
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
3/116 • Number of events 6 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
1.8%
2/109 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Bone marrow necrosis
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 4 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
1.8%
2/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
2.8%
3/109 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Cardiac disorders
Cardiac arrest
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Cardiac disorders
Cardiac failure
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Cardiac disorders
Coronary artery disease
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Eye disorders
Eye haemorrhage
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 4 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
1.8%
2/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
General physical health deterioration
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
1.8%
2/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Nodule
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Pyrexia
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 5 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Immune system disorders
Immune system disorder
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Bronchitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Campylobacter infection
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Cellulitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Clostridium difficile infection
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Covid-19
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
5.5%
6/109 • Number of events 6 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Covid-19 pneumonia
|
4.3%
5/116 • Number of events 7 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 4 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Device related infection
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Diverticulitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Escherichia sepsis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Infection
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Infectious pleural effusion
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Influenza
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Neutropenic sepsis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Osteomyelitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pharyngitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia
|
17.2%
20/116 • Number of events 29 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
11.0%
12/109 • Number of events 15 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia influenzal
|
2.6%
3/116 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia viral
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pulmonary sepsis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Sepsis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Sinusitis
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Urinary tract infection
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
1.8%
2/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Viral infection
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.1%
1/32 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
2.8%
3/109 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.7%
2/116 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Cerebral infarction
|
0.86%
1/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Dysarthria
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Headache
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Spinal cord compression
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Syncope
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Psychiatric disorders
Delirium
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Psychiatric disorders
Depression
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Renal and urinary disorders
Renal failure
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Renal and urinary disorders
Renal impairment
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.9%
1/34 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
1.8%
2/109 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Vascular disorders
Aortic dilatation
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Vascular disorders
Circulatory collapse
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.00%
0/109 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Vascular disorders
Haematoma
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
Other adverse events
| Measure |
Arm A - Pirtobrutinib
n=116 participants at risk
Participants received 200 mg of pirtobrutinib administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
n=109 participants at risk
Participants received either 150 mg of idelalisib administered BID orally on Days 1 through 28 of a 28-day cycle in combination with 375 mg/m\^2 of rituximab by IV infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 Q2W and 3 IV infusions of rituximab 500 mg/m\^2 Q4W or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.1%
21/116 • Number of events 29 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
19.3%
21/109 • Number of events 28 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.1%
21/116 • Number of events 44 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
15.6%
17/109 • Number of events 26 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
8/116 • Number of events 13 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
6.4%
7/109 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
4/116 • Number of events 4 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 10 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.86%
1/116 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
8/116 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
13.8%
15/109 • Number of events 18 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
20/116 • Number of events 25 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
27.5%
30/109 • Number of events 45 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Nausea
|
11.2%
13/116 • Number of events 15 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
21.1%
23/109 • Number of events 37 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Stomatitis
|
1.7%
2/116 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 11 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
7/116 • Number of events 10 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
16.5%
18/109 • Number of events 26 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Asthenia
|
8.6%
10/116 • Number of events 12 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
5.5%
6/109 • Number of events 10 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Chills
|
0.86%
1/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
8.3%
9/109 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Fatigue
|
13.8%
16/116 • Number of events 19 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
24.8%
27/109 • Number of events 29 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Oedema peripheral
|
11.2%
13/116 • Number of events 15 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
6.4%
7/109 • Number of events 8 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
General disorders
Pyrexia
|
12.1%
14/116 • Number of events 21 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
25.7%
28/109 • Number of events 35 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Bronchitis
|
2.6%
3/116 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 11 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Covid-19
|
12.1%
14/116 • Number of events 17 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
16.5%
18/109 • Number of events 21 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Pneumonia
|
12.9%
15/116 • Number of events 17 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 6 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
11/116 • Number of events 18 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
6.4%
7/109 • Number of events 8 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
8/116 • Number of events 13 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 4 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/116 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
14.7%
16/109 • Number of events 21 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
4/116 • Number of events 5 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
16.5%
18/109 • Number of events 29 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
6/116 • Number of events 7 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
11.9%
13/109 • Number of events 23 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Blood creatinine increased
|
6.0%
7/116 • Number of events 8 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 8 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Neutrophil count decreased
|
7.8%
9/116 • Number of events 18 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
17.4%
19/109 • Number of events 41 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Platelet count decreased
|
1.7%
2/116 • Number of events 6 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
11.9%
13/109 • Number of events 24 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
Weight decreased
|
3.4%
4/116 • Number of events 5 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
16.5%
18/109 • Number of events 19 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Investigations
White blood cell count decreased
|
1.7%
2/116 • Number of events 2 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
9.2%
10/109 • Number of events 34 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
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Metabolism and nutrition disorders
Decreased appetite
|
4.3%
5/116 • Number of events 5 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
13.8%
15/109 • Number of events 15 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.0%
7/116 • Number of events 10 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
3.7%
4/109 • Number of events 6 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.2%
6/116 • Number of events 10 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
4.6%
5/109 • Number of events 5 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
6/116 • Number of events 7 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 11 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
9/116 • Number of events 13 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
9.2%
10/109 • Number of events 11 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
10/116 • Number of events 12 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
4.6%
5/109 • Number of events 8 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Nervous system disorders
Dizziness
|
2.6%
3/116 • Number of events 3 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
8.3%
9/109 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
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Nervous system disorders
Headache
|
11.2%
13/116 • Number of events 14 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
13.8%
15/109 • Number of events 18 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.2%
20/116 • Number of events 22 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
18.3%
20/109 • Number of events 24 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
6/116 • Number of events 6 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
7.3%
8/109 • Number of events 12 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
7/116 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
0.92%
1/109 • Number of events 1 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
11/116 • Number of events 12 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
8.3%
9/109 • Number of events 11 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
|
Vascular disorders
Hypertension
|
7.8%
9/116 • Number of events 9 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
|
4.6%
5/109 • Number of events 5 • Baseline up to data cut-off date 29-August-2024 (up to 36 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Analyses presented in this report were based on a data cut off from 29 Aug 2024. For Arm B, adverse events were presented for Investigator's choice of Idelalisib Plus Rituximab (IR) or Bendamustine Plus Rituximab (BR) combined. Arm B adverse event data was not collected separately for IR and BR.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60