| Primary | Objective Response Rate (ORR) in Total Population Based on Investigator Assessment | The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response. | Full analysis set (FAS) and per protocol set (PPS) | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months) | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| | | Title | Denominators | Categories |
|---|
| Full analysis set (FAS) | | | | Per protocol set (PPS) | |
| |
| Primary | ORR by CD79b Status Based on Investigator Assessment | The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response. | Full analysis set (FAS) and per protocol set (PPS) | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months) | | | | ID | Title | Description |
|---|
| OG000 | CD79b Mutant | Included all participants with CD79b mutant classified at baseline depending on the biomarker value | | OG001 | CD79b Wild-type | Included all participants with CD79b wild-type classified at baseline depending on biomarker value | | OG002 | CD79b Status Missing | Included all participants with CD79b status missing at baseline |
| |
| Primary | ORR by DLBCL/COO Subtype Based on Investigator Assessment | The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response. | Full analysis set (FAS) and per protocol set (PPS) | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months) | | | | ID | Title | Description |
|---|
| OG000 | Activated B-cell-like (ABC) | Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value | | OG001 | Germinal Center B-cell-like (GCB) | Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value | | OG002 | Unclassifiable | Included all participants with unclassifiable DLBCL/COO subtype at baseline |
|
| Secondary | Duration of Response (DOR) in Total Population | The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Secondary | DOR by CD79b Status | The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | CD79b Mutant | Included all participants with CD79b mutant classified at baseline depending on the biomarker value | | OG001 | CD79b Wild-type | Included all participants with CD79b wild-type classified at baseline depending on biomarker value | | OG002 | CD79b Status Missing | Included all participants with CD79b status missing at baseline |
| |
| Secondary | DOR by DLBCL/COO Subtype | The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Activated B-cell-like (ABC) | Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value | | OG001 | Germinal Center B-cell-like (GCB) | Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value | | OG002 | Unclassifiable | Included all participants with unclassifiable DLBCL/COO subtype at baseline |
|
| Secondary | Progression-free Survival (PFS) in Total Population | The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Secondary | PFS by CD79b Status | The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | CD79b Mutant | Included all participants with CD79b mutant classified at baseline depending on the biomarker value | | OG001 | CD79b Wild-type | Included all participants with CD79b wild-type classified at baseline depending on biomarker value | | OG002 | CD79b Status Missing | Included all participants with CD79b status missing at baseline |
| |
| Secondary | PFS by DLBCL/COO Subtype | The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Activated B-cell-like (ABC) | Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value | | OG001 | Germinal Center B-cell-like (GCB) | Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value | | OG002 | Unclassifiable | Included all participants with unclassifiable DLBCL/COO subtype at baseline | | OG003 | DLBCL/COO Subtype Missing |
|
| Secondary | Overall Survival (OS) in Total Population | The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause. | | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Secondary | OS by CD79b Status | The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause. | | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | CD79b Mutant | Included all participants with CD79b mutant classified at baseline depending on the biomarker value | | OG001 | CD79b Wild-type | Included all participants with CD79b wild-type classified at baseline depending on biomarker value | | OG002 | CD79b Status Missing | Included all participants with CD79b status missing at baseline |
| |
| Secondary | OS by DLBCL/COO Subtype | The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause. | | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Activated B-cell-like (ABC) | Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value | | OG001 | Germinal Center B-cell-like (GCB) | Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value | | OG002 | Unclassifiable | Included all participants with unclassifiable DLBCL/COO subtype at baseline | | OG003 | DLBCL/COO Subtype Missing | Included all participants with DLBCL/COO subtype missing at baseline |
|
| Secondary | Duration of Stable Disease (DOSD) in Total Population | The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | Participants who failed to achieve CR or PR but achieved SD in full analysis set based on the investigator assessment | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Secondary | Disease Control Rate (DCR) in Total Population | The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Secondary | DCR by CD79b Status | The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | CD79b Mutant | Included all participants with CD79b mutant classified at baseline depending on the biomarker value | | OG001 | CD79b Wild-type | Included all participants with CD79b wild-type classified at baseline depending on biomarker value | | OG002 | CD79b Status Missing | Included all participants with CD79b status missing at baseline |
| |
| Secondary | DCR by DLBCL/COO Subtype | The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Activated B-cell-like (ABC) | Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value | | OG001 | Germinal Center B-cell-like (GCB) | Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value | | OG002 | Unclassifiable | Included all participants with unclassifiable DLBCL/COO subtype at baseline | | OG003 |
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application. | Safety analysis set (SAF) | Posted | | Number | | Participants | | From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Other Pre-specified | Time to Response (TTR) in Total Population | The time to response (TTR) was defined as the time (days) from start of study treatment to the date of first observed response (first measured CR or PR). TTR was defined for responders only (i.e. participants with CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. | Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment | Posted | | Median | 95% Confidence Interval | Days | | From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Other Pre-specified | ORR in Total Population Based on Central Imaging Review | The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months) | | | | ID | Title | Description |
|---|
| OG000 | Copanlisib (Aliqopa, BAY80-6946) | Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment |
| |
| Other Pre-specified | ORR by CD79b Status Based on Central Imaging Review | The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months) | | | | ID | Title | Description |
|---|
| OG000 | CD79b Mutant | Included all participants with CD79b mutant classified at baseline depending on the biomarker value | | OG001 | CD79b Wild-type | Included all participants with CD79b wild-type classified at baseline depending on biomarker value | | OG002 | CD79b Status Missing | Included all participants with CD79b status missing at baseline |
| |
| Other Pre-specified | ORR by DLBCL/COO Subtype Based on Central Imaging Review | The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months) | | | | ID | Title | Description |
|---|
| OG000 | Activated B-cell-like (ABC) | Included all participants with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value | | OG001 | Germinal Center B-cell-like (GCB) | Included all participants with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value | | OG002 | Unclassifiable | Included all participants with unclassifiable DLBCL/COO subtype at baseline |
|