Trial Outcomes & Findings for Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma (NCT NCT03789240)

Last Updated: 2026-03-03

Results Overview

The response rate will be determined and reported along with a 95% confidence interval. Complete Response was assessed by the Lugano Classification of Response Criteria and is defined as the proportion of participants who achieve a PET-negative complete response in accordance with the 2014 Lugano classification of the International Working Group Criteria for Non-Hodgkin's Lymphoma after induction therapy with copanlisib and rituximab. Under the Lugano criteria (2014), a Complete Response is defined by a Deauville score of 1-3 on PET and no evidence of disease in the bone marrow, with or without a residual mass.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Within 2 months of induction therapy completion, up to 13 months since start of therapy

Results posted on

2026-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Overall Study STARTED	33
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Overall Study Switched to alternative treatment	4
Overall Study Physician Decision	1

Baseline Characteristics

Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=41 Participants
Age, Categorical >=65 years	10 Participants n=41 Participants
Age, Continuous	55 years n=41 Participants
Sex: Female, Male Female	16 Participants n=41 Participants
Sex: Female, Male Male	17 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	4 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	5 Participants n=41 Participants
Race (NIH/OMB) White	23 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants
Region of Enrollment United States	33 participants n=41 Participants

PRIMARY outcome

Timeframe: Within 2 months of induction therapy completion, up to 13 months since start of therapy

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Proportion of Participants Who Achieve Positron Emission Tomography (PET) - Negative Complete Response	0.48 proportion of participants Interval 0.31 to 0.66

SECONDARY outcome

Timeframe: Through study induction therapy period and until 1 month after completion of induction

The proportion of participants with adverse events leading to discontinuation of induction therapy with copanlisib and rituximab.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Induction Therapy With Copanlisib and Rituximab	0.18 proportion of participants Interval 0.1 to 0.53

SECONDARY outcome

Timeframe: Through 30 months from study enrollment

The response rate will be determined and reported along with a 95% confidence interval. Complete Response was assessed by the Lugano Classification of Response Criteria and is defined as the proportion of participants who achieve a positron emission tomography (PET)-negative complete response in accordance with the 2014 Lugano classification of the International Working Group Criteria for Non-Hodgkin's Lymphoma after induction therapy with copanlisib and rituximab. CR30 refers to the proportion of participants who remain in complete response at 30 months from study enrollment. Under the Lugano criteria (2014), a Complete Response is defined by a Deauville score of 1-3 on PET and no evidence of disease in the bone marrow, with or without a residual mass.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Proportion of Participants With a Continuous Complete Response Rate at 30 Months (CR30)	0.27 proportion of participants Interval 0.13 to 0.46

SECONDARY outcome

Timeframe: Through study induction therapy period and until 1 month after completion of induction

The proportion of participants who achieve both a complete response and are negative on molecular assays for minimal residual disease after induction therapy with copanlisib and rituximab. Under the Lugano criteria (2014), a Complete Response is defined by a Deauville score of 1-3 on positron emission tomography (PET) and no evidence of disease in the bone marrow, with or without a residual mass. Minimal residual disease was defined as detection of circulating tumor deoxyribonucleic acid (DNA) after completion of induction therapy in blood.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Complete Molecular Remission (CMR) Rate Defined as the Proportion of Participants Who Achieve Both a Complete Response and Are Negative on Molecular Assays for Minimal Residual Disease After Induction Therapy With Copanlisib and Rituximab	0.56 proportion of participants Interval 0.37 to 0.73

SECONDARY outcome

Timeframe: Through study induction therapy period and until 1 month after completion of induction

Objective response rate (ORR) defined as the proportion of participants who achieve at least a partial response (PR) to induction therapy with copanlisib and rituximab. Partial response was defined using the 2014 Lugano classification for lymphoma and defined as a decrease in the sum of the product of the diameters (SPD) of up to six of the largest nodes or nodal masses.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Objective Response Rate (ORR) Defined as the Proportion of Participants Who Achieve at Least a Partial Response (PR) to Induction Therapy With Copanlisib and Rituximab	0.91 proportion of participants Interval 0.76 to 0.98

SECONDARY outcome

Timeframe: 6 years

DOR is defined as time from first documentation of tumor response to disease progression. Progression was defined as evidence of disease growth, recurrence, or new disease based on imaging (computed tomography (CT) or positron-emission tomography (PET/CT) and clinical evaluation.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Duration of Response (DOR)	1.2 Years Interval 0.84 to 3.15

SECONDARY outcome

Timeframe: time from the end of induction therapy with copanlisib and rituximab until initiation of next treatment, up to 6 years

TTNT is the time from the end of induction therapy with copanlisib and rituximab until initiation of next treatment. Induction therapy is combination therapy with copanlisib and rituximab, and next treatment is start of any systemic therapy after completion of induction therapy with copanlisib and rituximab.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Time to Next Treatment (TTNT)	3.4 Years Interval 1.48 to The upper bound confidence interval is not estimable because we did not have enough number of events required to accurately calculate the limits of the confidence interval.

SECONDARY outcome

Timeframe: time from study enrollment until disease progression or death from any cause, up to 6 years

PFS is the time from study enrollment until disease progression or death from any cause. Disease progression was defined as evidence of disease growth, recurrence, or new disease based on imaging (computed tomography (CT) or positron-emission tomography (PET/CT) and clinical evaluation.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Progression Free Survival (PFS)	1.3 Years Interval 1.08 to 3.45

SECONDARY outcome

Timeframe: time from study enrollment until death from any cause, up to 6 years

OS is the time from study enrollment until death from any cause.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Overall Survival (OS)	NA Years The median and 95% confidence interval was not reached because less than half of the participants died, and we did not have enough number of events required to accurately calculate the median and limits of the confidence intervals.

OTHER_PRE_SPECIFIED outcome

Timeframe: Adverse events were monitored/assessed from the first administration of study drug through 30 days post the last administration of study drug.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 Participants Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	31 Participants

Adverse Events

Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab

Serious events: 12 serious events

Other events: 31 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 participants at risk Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Immune system disorders Allergic reaction	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Bacteremia	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Catheter related infection	3.0% 1/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Enterocolitis infectious	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Blood and lymphatic system disorders Febrile neutropenia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Immune system disorders Immune system disorders - Other, specify	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Infections and infestations - Other, specify: COVID 19	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Infections and infestations - Other, specify: COVID-19	9.1% 3/33 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Infections and infestations - Other, specify: Viral Infection, other	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Injury, poisoning and procedural complications Infusion related reaction	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Lung infection	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify: DIABETES	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Urinary Tract Obstruction	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Cardiac disorders Sinus bradycardia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Cellulitis	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Vascular disorders Vascular disorders - Other, specify: Thrombolic event	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.

Other adverse events

Other adverse events
Measure	Dose Level 1: 60mg of Copanlisib and 375mg/m^2 Rituximab n=33 participants at risk Untreated Follicular Lymphoma (FL) (Stage II-IV) and stage I FL who have been treated with radiation therapy and have subsequently relapsed (up to a maximum of 65 participants). Window of treatment with Copanlisib 60mg via intravenous for a single 28-day cycle, once weekly for the first 3 weeks and then a 1-week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m\^2 via intravenous, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Gastrointestinal disorders Abdominal pain	9.1% 3/33 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Alanine aminotransferase increased	18.2% 6/33 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Immune system disorders Allergic reaction	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Anal mucositis	6.1% 2/33 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Psychiatric disorders Anxiety	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Aspartate aminotransferase increased	18.2% 6/33 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Bloating	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Eye disorders Blurred vision	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Bone pain	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Cardiac disorders Cardiac disorders - Other, specify: Small Vessel Disease	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Constipation	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Creatinine increased	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Diarrhea	30.3% 10/33 • Number of events 11 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Nervous system disorders Dizziness	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Eye disorders Dry eye	9.1% 3/33 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Dry mouth	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Dry skin	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Nervous system disorders Dysgeusia	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Dyspepsia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
General disorders Edema limbs	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Endocrine disorders Endocrine disorders - Other, specify: Night sweats	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Blood and lymphatic system disorders Eosinophilia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Eye disorders Eye disorders - Other, specify: Left Eye Stye	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
General disorders Fatigue	9.1% 3/33 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Flank pain	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
General disorders Flu like symptoms	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Gastric ulcer	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Gastritis	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Gastroesophageal reflux disease	9.1% 3/33 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Heart-Burn	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Nervous system disorders Headache	12.1% 4/33 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Renal and urinary disorders Hematuria	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Hemorrhoids	3.0% 1/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Hyperglycemia	9.1% 3/33 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Hyperkalemia	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Vascular disorders Hypertension	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Hypocalcemia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Hypokalemia	9.1% 3/33 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Hypomagnesemia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Metabolism and nutrition disorders Hyponatremia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Infections and infestations - Other, specify: COVID-19	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Infections and infestations - Other, specify: Viral infection, other	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Infusion related reaction	27.3% 9/33 • Number of events 11 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Psychiatric disorders Insomnia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Lipase increased	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Lymphocyte count increased	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Mucositis oral	39.4% 13/33 • Number of events 33 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Muscle cramp	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Knee Pain	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Myalgias	9.1% 3/33 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Nausea	42.4% 14/33 • Number of events 15 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Neutrophil count decreased	18.2% 6/33 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Oral dysesthesia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Papulopustular rash	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Phlebitis	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Platelet count decreased	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Rash maculo-papular	60.6% 20/33 • Number of events 32 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Rash pustular	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Eye disorders Retinal tear	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Rhinitis infective	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Cardiac disorders Sinus bradycardia	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Sinus pain	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Sinusitis	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Itching	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Mild Erythema	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Skin infection	6.1% 2/33 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Respiratory, thoracic and mediastinal disorders Sore throat	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Vascular disorders Superficial thrombophlebitis	21.2% 7/33 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Ear and labyrinth disorders Tinnitus	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Infections and infestations Upper respiratory infection	15.2% 5/33 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Reproductive system and breast disorders Vaginal discharge	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Reproductive system and breast disorders Vaginal hemorrhage	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Ear and labyrinth disorders Vertigo	3.0% 1/33 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Gastrointestinal disorders Vomiting	15.2% 5/33 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.
Investigations Weight loss	6.1% 2/33 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from the first administration of study drug through end of follow-up, up to 6 years. Dose reductions are part of any study conduct thus we did not report adverse events separately for this phase 2 study. There were in fact two participants who had dose reductions due to toxicity. This is in contrast to dose levels in a phase 1 study where the goal is to determine the maximum tolerated dose of a drug and should be reported separately.

Additional Information

Rahul Lakhotia, M.B.B.S.

National Cancer Institute

Phone: 240-858-7242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place