Trial Outcomes & Findings for Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) (NCT NCT02367040)
NCT ID: NCT02367040
Last Updated: 2025-10-14
Results Overview
Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 years
Results posted on
2025-10-14
Participant Flow
The study was conducted at multiple centers in North America, South America, South Africa, Europe, Asia, and Australia between 03 August 2015 (first participant first visit) and 15 November 2024 (last participant first visit).
Overall, 652 were screened and total of 458 participants were randomized in a 2:1 ratio to study treatment: 307 participants to copanlisib/rituximab and 151 participants to placebo/rituximab.
Participant milestones
| Measure |
Copanlisib + Rituximab
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Overall Study
STARTED
|
307
|
151
|
|
Overall Study
Received Treatment
|
304
|
149
|
|
Overall Study
COMPLETED
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
307
|
147
|
Reasons for withdrawal
| Measure |
Copanlisib + Rituximab
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Additional primary malignancy
|
1
|
1
|
|
Overall Study
AE not associated with clinical disease progression
|
117
|
12
|
|
Overall Study
AE associated with clinical disease progression
|
1
|
4
|
|
Overall Study
Physician Decision
|
2
|
8
|
|
Overall Study
Non-compliance to study drug
|
1
|
0
|
|
Overall Study
Failure to meet continuation criteria
|
1
|
0
|
|
Overall Study
Switching to other therapy
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
51
|
16
|
|
Overall Study
Patient decision: COVID-19 pandemic related
|
1
|
0
|
|
Overall Study
Patient decision
|
40
|
14
|
|
Overall Study
Required procedure failed
|
1
|
0
|
|
Overall Study
Randomized by mistake with study treatment
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Progressive disease - radiological progression
|
54
|
80
|
|
Overall Study
Progressive disease - clinical progression
|
6
|
6
|
|
Overall Study
Drug not administered
|
3
|
2
|
|
Overall Study
Progressive disease
|
0
|
1
|
|
Overall Study
Other reason: Covid-19 pandemic related
|
1
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Study terminated by sponsor
|
19
|
2
|
Baseline Characteristics
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
Baseline characteristics by cohort
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
262 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
380 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
125 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Eastern cooperative oncology group (ECOG) Performance Status (PS)
0 - Fully active
|
182 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Eastern cooperative oncology group (ECOG) Performance Status (PS)
1 - Restricted active
|
113 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Eastern cooperative oncology group (ECOG) Performance Status (PS)
2 - Ambulatory and capable of all self-care
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 yearsPopulation: All randomized participants (FAS=full analysis set) were included.
Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section).
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Progression Free Survival (PFS) Based on Independent Central Review.
At data cut-off=31-Aug-2020
|
21.5 Months
Interval 17.8 to 33.0
|
13.8 Months
Interval 10.2 to 17.5
|
|
Progression Free Survival (PFS) Based on Independent Central Review.
At data cut-off=31-Aug-2022
|
23.2 Months
Interval 19.4 to 33.0
|
13.8 Months
Interval 10.8 to 17.5
|
|
Progression Free Survival (PFS) Based on Independent Central Review.
At data cut-off=15-Nov-2024
|
22.4 Months
Interval 19.7 to 30.7
|
14.0 Months
Interval 11.4 to 19.2
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Objective response rate (ORR) was defined as the percentage of participants who have a best response rating over the whole duration of the study (i.e. until time of analysis of PFS) of complete response (CR) or partial response (PR) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of CR, very good partial response (VGPR), PR, or minor response (MR) according to the Owen Criteria (kindly refer to the links in the Protocol section).
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Objective Response Rate (ORR)
At data cut-off=31-Aug-2020
|
80.8 Percentage of participants
|
47.7 Percentage of participants
|
|
Objective Response Rate (ORR)
At data cut-off=31-Aug-2022
|
80.5 Percentage of participants
|
49.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Complete response rate (CRR) was defined as the percentage of participants who had a best response rating over the whole duration of the study (i.e., until the time of analysis of PFS) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of Complete Response according to the Owen Criteria (kindly refer to the links in the Protocol section).
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Complete Response Rate (CRR)
At data cut-off=31-Aug-2020
|
33.9 Percentage of participants
|
14.6 Percentage of participants
|
|
Complete Response Rate (CRR)
At data cut-off=31-Aug-2022
|
34.2 Percentage of participants
|
15.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Duration of response (DOR) was defined as the time (in days) from first observed tumor response Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) or Minor Response (MR) until progression or death from any cause, whichever occurred earlier according to the Owen Criteria (kindly refer to the links in the Protocol section). Only patients with response in FAS were included in the analysis.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Duration of Response (DOR)
At data cut-off=31-Aug-2020
|
20.4 Months
Interval 17.0 to 30.8
|
17.3 Months
Interval 11.8 to 25.3
|
|
Duration of Response (DOR)
At data cut-off=31-Aug-2022
|
25.9 Months
Interval 17.7 to 31.5
|
15.2 Months
Interval 12.3 to 25.3
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Disease control rate was defined as the percentage of participants who had a best response rating as Complete Response (CR), Partial Response (PR) or stable disease (SD) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) as a response rating of CR, very good partial response (VGPR), PR, minor response (MR) or stable disease (SD) according to the Owen Criteria (kindly refer to the links in the Protocol section).
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Disease Control Rate (DCR)
At data cut-off=31-Aug-2022
|
89.3 Percentage of participants
|
84.8 Percentage of participants
|
|
Disease Control Rate (DCR)
At data cut-off=31-Aug-2020
|
89.3 Percentage of participants
|
84.8 Percentage of participants
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Time to progression (TTP) was defined as the time (days) from date of randomization to date of first observed disease progression according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section).
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Time to Progression (TTP)
At data cut-off=31-Aug-2020
|
22.3 Months
Interval 19.4 to 33.2
|
13.8 Months
Interval 10.8 to 18.7
|
|
Time to Progression (TTP)
At data cut-off=31-Aug-2022
|
27.7 Months
Interval 21.9 to 33.3
|
13.8 Months
Interval 11.0 to 18.7
|
SECONDARY outcome
Timeframe: From randomization up to the final analysis at 15-Nov-2024 up to 9 yearsPopulation: All randomized patients (FAS) were included.
Overall survival was defined as the time (in days) from randomization until death from any cause.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 82.2 to
Value could not be estimated because of censored data (insufficient number of participants with events).
|
NA Months
Interval 77.3 to
Value could not be estimated because of censored data (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Time to deterioration in DRS-P (Disease-Related Symptoms - Physical) of at least three points was defined as the time (in days) from randomization to DRS-P decline, progression, or death due to any reason, whichever occurred earlier. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
At data cut-off=31-Aug-2020
|
5.5 Months
Interval 4.2 to 5.9
|
5.5 Months
Interval 4.0 to 7.4
|
|
Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
At data cut-off=31-Aug-2022
|
5.5 Months
Interval 4.2 to 5.9
|
5.5 Months
Interval 4.1 to 7.4
|
SECONDARY outcome
Timeframe: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 yearsPopulation: All randomized participants (FAS) were included.
Time to improvement in DRS-P (Disease-Related Symptoms - Physical) was defined as the time (in days) from randomization to DRS-P improvement of at least three points. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=151 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
At data cut-off=31-Aug-2020
|
NA Months
Interval 8.3 to
NA = value cannot be estimated due to censored data (insufficient number of events).
|
NA Months
Interval 6.0 to
NA = value cannot be estimated due to censored data (insufficient number of events).
|
|
Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
At data cut-off=31-Aug-2022
|
38.5 Months
Interval 8.2 to
NA = value cannot be estimated due to censored data (insufficient number of events).
|
35.7 Months
Interval 5.9 to
NA = value cannot be estimated due to censored data (insufficient number of events).
|
SECONDARY outcome
Timeframe: Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization datePopulation: Participants in safety analysis set (SAF) with evaluable data reported.
Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=146 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date.
Any TEAEs
|
307 Participants
|
134 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date.
Any copanlisib- or placebo-related TEAE
|
293 Participants
|
95 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date.
Any rituximab-related TEAE
|
218 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after end of treatment with study drug, data reporting cut-off at 7 years from the first participant randomization datePopulation: Participants in safety analysis set (SAF) with evaluable data reported.
Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=146 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date.
Any copanlisib- or placebo-related TEAE
|
295 Participants
|
98 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date.
Any TEAEs
|
307 Participants
|
137 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date.
Any rituximab-related TEAE
|
218 Participants
|
93 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after end of treatment with study drug, data reporting cut-off at final analysis, up to 9 yearsPopulation: Participants in safety analysis set (SAF) with evaluable data reported.
Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Outcome measures
| Measure |
Copanlisib + Rituximab
n=307 Participants
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=146 Participants
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis
Any TEAEs
|
307 Participants
|
137 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis
Any copanlisib- or placebo-related TEAE
|
295 Participants
|
98 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis
Any rituximab-related TEAE
|
218 Participants
|
93 Participants
|
Adverse Events
Copanlisib + Rituximab
Serious events: 161 serious events
Other events: 298 other events
Deaths: 99 deaths
Placebo + Rituximab
Serious events: 32 serious events
Other events: 127 other events
Deaths: 50 deaths
Serious adverse events
| Measure |
Copanlisib + Rituximab
n=307 participants at risk
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=146 participants at risk
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
3/307 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
4/307 • Number of events 7 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.1%
3/146 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Cardiac disorders
Eustachian valve hypertrophy
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Anal fissure
|
0.33%
1/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Colitis
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Enteritis
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Asthenia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Death
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Fatigue
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Generalised oedema
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Mucosal inflammation
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Pain
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Pyrexia
|
1.6%
5/307 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Administration site extravasation
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Hepatobiliary disorders
Biliary colic
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Immune system disorders
Anaphylactic reaction
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Immune system disorders
Hypersensitivity
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Appendicitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Atypical pneumonia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Bronchiolitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Bronchitis
|
0.98%
3/307 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Endocarditis bacterial
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
4/307 • Number of events 4 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Herpes zoster
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.98%
3/307 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Oral candidiasis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Parvovirus B19 infection
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumonia
|
7.2%
22/307 • Number of events 25 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
3.4%
5/146 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumonia viral
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Sinusitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Subcutaneous abscess
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.65%
2/307 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
4/307 • Number of events 4 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Viral infection
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Urosepsis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Anal abscess
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Neutropenic sepsis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumonia bacterial
|
1.3%
4/307 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Penile infection
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Respiratory tract infection
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Device related infection
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
2.6%
8/307 • Number of events 8 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
COVID-19
|
2.6%
8/307 • Number of events 9 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.1%
3/146 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Fall
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Amylase increased
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Blood calcium increased
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Lipase increased
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Neutrophil count decreased
|
1.6%
5/307 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Influenza A virus test positive
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
21/307 • Number of events 27 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.98%
3/307 • Number of events 3 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Cerebral infarction
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Neuralgia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Syncope
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Tension headache
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Seizure like phenomena
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/307 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
6/307 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.9%
15/307 • Number of events 15 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
4/307 • Number of events 4 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Surgical and medical procedures
Ureteral stent removal
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Surgical and medical procedures
Arthrodesis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Vascular disorders
Hypertension
|
1.3%
4/307 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Vascular disorders
Thrombosis
|
0.33%
1/307 • Number of events 1 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Vascular disorders
Deep vein thrombosis
|
0.65%
2/307 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.00%
0/146 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
Other adverse events
| Measure |
Copanlisib + Rituximab
n=307 participants at risk
Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
|
Placebo + Rituximab
n=146 participants at risk
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m\^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.5%
60/307 • Number of events 139 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
11.0%
16/146 • Number of events 62 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.8%
64/307 • Number of events 249 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
16.4%
24/146 • Number of events 57 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
13/307 • Number of events 32 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
5.5%
8/146 • Number of events 14 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
17/307 • Number of events 23 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.1%
6/146 • Number of events 7 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Constipation
|
10.1%
31/307 • Number of events 37 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.2%
12/146 • Number of events 14 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.5%
106/307 • Number of events 245 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
10.3%
15/146 • Number of events 19 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.8%
21/307 • Number of events 31 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Nausea
|
22.8%
70/307 • Number of events 116 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
11.6%
17/146 • Number of events 25 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Stomatitis
|
13.4%
41/307 • Number of events 59 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 9 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Gastrointestinal disorders
Vomiting
|
14.7%
45/307 • Number of events 62 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
3.4%
5/146 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Asthenia
|
6.8%
21/307 • Number of events 27 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
3.4%
5/146 • Number of events 7 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Chills
|
7.2%
22/307 • Number of events 33 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.8%
7/146 • Number of events 10 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Fatigue
|
14.3%
44/307 • Number of events 51 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
7.5%
11/146 • Number of events 16 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Influenza like illness
|
5.5%
17/307 • Number of events 19 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.8%
7/146 • Number of events 10 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Mucosal inflammation
|
5.9%
18/307 • Number of events 23 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
General disorders
Pyrexia
|
19.9%
61/307 • Number of events 93 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
9.6%
14/146 • Number of events 21 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Bronchitis
|
5.9%
18/307 • Number of events 30 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
5.5%
8/146 • Number of events 9 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Influenza
|
2.6%
8/307 • Number of events 9 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.2%
12/146 • Number of events 14 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
28/307 • Number of events 41 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.8%
7/146 • Number of events 12 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Pneumonia
|
11.7%
36/307 • Number of events 54 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.2%
12/146 • Number of events 15 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.2%
62/307 • Number of events 124 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
19.2%
28/146 • Number of events 37 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Urinary tract infection
|
12.4%
38/307 • Number of events 67 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.9%
13/146 • Number of events 20 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
Oral herpes
|
6.2%
19/307 • Number of events 29 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Infections and infestations
COVID-19
|
6.8%
21/307 • Number of events 28 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.1%
6/146 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Alanine aminotransferase increased
|
9.8%
30/307 • Number of events 46 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
7.5%
11/146 • Number of events 20 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Amylase increased
|
5.2%
16/307 • Number of events 20 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 13 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
28/307 • Number of events 37 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.2%
12/146 • Number of events 22 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Blood bilirubin increased
|
5.2%
16/307 • Number of events 31 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 4 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Blood cholesterol increased
|
4.2%
13/307 • Number of events 14 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
5.5%
8/146 • Number of events 15 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.1%
25/307 • Number of events 41 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.8%
7/146 • Number of events 11 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Blood creatinine increased
|
5.2%
16/307 • Number of events 26 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.1%
6/146 • Number of events 7 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Lipase increased
|
5.9%
18/307 • Number of events 39 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 16 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Lymphocyte count decreased
|
13.7%
42/307 • Number of events 122 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
6.2%
9/146 • Number of events 38 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Neutrophil count decreased
|
33.2%
102/307 • Number of events 434 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
23.3%
34/146 • Number of events 74 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Platelet count decreased
|
13.7%
42/307 • Number of events 121 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.2%
12/146 • Number of events 23 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
Weight decreased
|
15.3%
47/307 • Number of events 67 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Investigations
White blood cell count decreased
|
19.9%
61/307 • Number of events 315 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
11.6%
17/146 • Number of events 53 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
68.4%
210/307 • Number of events 940 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
24.0%
35/146 • Number of events 93 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.8%
21/307 • Number of events 35 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.8%
7/146 • Number of events 23 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.5%
20/307 • Number of events 33 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
5.5%
8/146 • Number of events 18 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
25/307 • Number of events 38 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
0.68%
1/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.5%
23/307 • Number of events 28 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 4 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
21/307 • Number of events 24 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
6.2%
9/146 • Number of events 15 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
19/307 • Number of events 21 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
8.9%
13/146 • Number of events 17 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
19/307 • Number of events 26 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
8/307 • Number of events 10 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
7.5%
11/146 • Number of events 12 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
19/307 • Number of events 27 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
3.4%
5/146 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Dizziness
|
5.2%
16/307 • Number of events 19 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.1%
6/146 • Number of events 6 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Dysgeusia
|
6.8%
21/307 • Number of events 28 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Nervous system disorders
Headache
|
14.0%
43/307 • Number of events 73 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
6.8%
10/146 • Number of events 20 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Psychiatric disorders
Insomnia
|
5.9%
18/307 • Number of events 19 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
3.4%
5/146 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.3%
47/307 • Number of events 69 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
13.0%
19/146 • Number of events 30 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
17/307 • Number of events 17 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
9.6%
14/146 • Number of events 18 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
18/307 • Number of events 21 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
4.1%
6/146 • Number of events 7 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
20/307 • Number of events 22 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
1.4%
2/146 • Number of events 2 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
30/307 • Number of events 39 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
6.2%
9/146 • Number of events 12 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
35/307 • Number of events 51 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
6.8%
10/146 • Number of events 13 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.8%
21/307 • Number of events 33 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
2.7%
4/146 • Number of events 5 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
|
Vascular disorders
Hypertension
|
51.1%
157/307 • Number of events 779 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
21.2%
31/146 • Number of events 119 • - Time frame for Serious and Other Adverse Events - from first administration of study drug until 30 days after the last study drug intake. - Time frame for number of death (all causes) - from randomization up to approximately 9 years.
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60