Trial Outcomes & Findings for Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma (NCT NCT03311126)
NCT ID: NCT03311126
Last Updated: 2024-10-24
Results Overview
For each patient, progression-free survival (PFS) is measured from cycle 1 day 1 (C1D1) of induction chemoimmunotherapy to the day patient experiences an event of disease progression or death, whichever occurs first. If a patient has not experienced an event at the time of analysis, patient's data will be censored at the date of the last available evaluation. The 2-year PFS probability will be estimated using the Kaplan-Meier method. From the date of C1D1 of induction therapy to the date of progression or death; in the absence of progression or death, participants will be followed for a minimum of 24 months after completion of study-related treatment. PFS rates at 2 years are reported here.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-10-24
Participant Flow
Participants were enrolled at UW Hospital and Clinics in Madison, WI, UW Cancer Center at ProHealth in Waukesha, WI, and St. Vincent Regional Cancer Center in Green Bay, WI from September 2017 to January 2022.
Participant milestones
| Measure |
Bendamustine + Obinutuzumab (BO)
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
Bendamustine: Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of chronic lymphocytic leukemia (CLL) and for indolent B cell non-Hodgkin lymphomas (NHLs) progressing during or within 6 months of rituximab or a rituximab - containing regimen.
Obinutuzumab: Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 monoclonal antibodies (mAb).
|
|---|---|
|
Induction
STARTED
|
21
|
|
Induction
Induction Chemotherapy Cycle 4
|
21
|
|
Induction
COMPLETED
|
20
|
|
Induction
NOT COMPLETED
|
1
|
|
Consolidation
STARTED
|
20
|
|
Consolidation
COMPLETED
|
20
|
|
Consolidation
NOT COMPLETED
|
0
|
|
Restaging Imaging
STARTED
|
20
|
|
Restaging Imaging
Radiographic Complete Response
|
10
|
|
Restaging Imaging
Lack of Radiographic Complete Response
|
10
|
|
Restaging Imaging
COMPLETED
|
10
|
|
Restaging Imaging
NOT COMPLETED
|
10
|
|
Maintenance
STARTED
|
10
|
|
Maintenance
Discontinued Maintenance Early
|
6
|
|
Maintenance
Completed All 8 Cycles
|
4
|
|
Maintenance
COMPLETED
|
10
|
|
Maintenance
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Bendamustine + Obinutuzumab (BO)
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
Bendamustine: Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of chronic lymphocytic leukemia (CLL) and for indolent B cell non-Hodgkin lymphomas (NHLs) progressing during or within 6 months of rituximab or a rituximab - containing regimen.
Obinutuzumab: Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 monoclonal antibodies (mAb).
|
|---|---|
|
Induction
Death
|
1
|
|
Restaging Imaging
Radiographic Complete Response moved to Observation rather than Maintenance
|
10
|
Baseline Characteristics
number of participants with confirmed p53 testing
Baseline characteristics by cohort
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
Bendamustine: Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of CLL and for indolent B cell NHLs progressing during or within 6 months of rituximab or a rituximab - containing regimen.
Obinutuzumab: Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 mAb.
|
|---|---|
|
Age, Customized
50-59 years
|
1 Participants
n=21 Participants
|
|
Age, Customized
60-69 years
|
8 Participants
n=21 Participants
|
|
Age, Customized
70-79 years
|
9 Participants
n=21 Participants
|
|
Age, Customized
80-89 years
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
|
ECOG Performance Status
ECOG Performance Status 0
|
9 Participants
n=21 Participants
|
|
ECOG Performance Status
ECOG Performance Status 1
|
9 Participants
n=21 Participants
|
|
ECOG Performance Status
ECOG Performance Status 2
|
3 Participants
n=21 Participants
|
|
Stage
Stage II
|
1 Participants
n=21 Participants
|
|
Stage
Stage III
|
0 Participants
n=21 Participants
|
|
Stage
Stage IV
|
20 Participants
n=21 Participants
|
|
MIPI Score
Low Risk
|
1 Participants
n=21 Participants
|
|
MIPI Score
Intermediate Risk
|
6 Participants
n=21 Participants
|
|
MIPI Score
High Risk
|
14 Participants
n=21 Participants
|
|
Prior Treatment
|
1 Participants
n=21 Participants
|
|
Bulky Nodes
|
7 Participants
n=21 Participants
|
|
Marrow Involvement
|
20 Participants
n=21 Participants
|
|
LDH elevation
|
9 Participants
n=21 Participants
|
|
Splenomegaly
|
10 Participants
n=21 Participants
|
|
P53 mutation status
|
3 Participants
n=12 Participants • number of participants with confirmed p53 testing
|
PRIMARY outcome
Timeframe: Up to 2 yearsFor each patient, progression-free survival (PFS) is measured from cycle 1 day 1 (C1D1) of induction chemoimmunotherapy to the day patient experiences an event of disease progression or death, whichever occurs first. If a patient has not experienced an event at the time of analysis, patient's data will be censored at the date of the last available evaluation. The 2-year PFS probability will be estimated using the Kaplan-Meier method. From the date of C1D1 of induction therapy to the date of progression or death; in the absence of progression or death, participants will be followed for a minimum of 24 months after completion of study-related treatment. PFS rates at 2 years are reported here.
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Progression Free Survival (PFS) at 2 Years
|
66 percent participants
Interval 41.6 to 82.2
|
SECONDARY outcome
Timeframe: At the end of Cycle 2 of induction therapy (each cycle is 28 days), following consolidation phase (after 6 cycles of induction, consolidation is 4 weekly doses of obinutuzumab), within 30 days of completing protocol therapy (up to 15 months total)Population: one participant died during the Induction Phase
MRD defined as reduction to \>=10\^-6 fold reduction in the IgVH unique clone of mantle cell lymphoma (MCL) by next generation (NGS). MRD status will be evaluated after 2 cycles of induction chemoimmunotherapy with bendamustine and obinutuzumab, after 4 cycles of consolidation with obinutuzumab, and after an additional 8 cycles of maintenance with obinutuzumab. MRD status will be summarized using frequency and proportion with 95% confidence intervals. MRD status will be collected on peripheral blood after cycle 2 of induction therapy, on peripheral blood and bone marrow aspirate after consolidation obinutuzumab, and peripheral blood after maintenance therapy completion.
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=20 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Minimal Residual Disease (MRD) Status
MRD negative (blood) after Induction Phase
|
13 Participants
|
|
Minimal Residual Disease (MRD) Status
MRD negative (blood and marrow) post-Consolidation Phase
|
10 Participants
|
|
Minimal Residual Disease (MRD) Status
MRD negative (blood only) post-Consolidation Phase
|
6 Participants
|
SECONDARY outcome
Timeframe: At the end of Cycle 2 of induction therapy (each cycle is 28 days), following consolidation phase of therapy (after 6 cycles of induction, consolidation is 4 weekly doses of obinutuzumab), and within 30 days of completing protocol therapyPopulation: one participant died during the Induction Phase
Concordance between PB and BMA in predicting MRD negative status will be summarized by percent of subjects in which MRD status is concordant (i.e., both positive in the PB and BMA or both negative in the PB and BMA).
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=20 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Estimate the Concordance Rate Between Peripheral Blood (PB) and Bone Marrow Aspirates (BMA) in Predicting MRD Status.
|
14 Participants
|
SECONDARY outcome
Timeframe: Assessed up to cycle 8 of maintenance therapy, up to 15 months on studyPopulation: one participant died during the Induction Phase
Lugano criteria will be used to assess radiographic response by CT and/or positron emission tomography (PET) imaging. Imaging for response assessment will be performed after 4 cycles of induction therapy, after consolidation obinutuzumab, and after cycles 4 and 8 of maintenance obinutuzumab. Bone marrow biopsy will be performed verify complete responses. Assessed as the best response over the course of therapy from any of the following time points: at the end of induction cycle 4 (each cycle is 28 days), after consolidation therapy (post-induction, consolidation is 4 weekly doses Obinutuzumab), and after Cycles 4 and 8 of Maintenance Obinutuzumab (each cycle is 8 weeks).
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=20 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Determine Objective Response Rates (CR + PR) With Induction Bendamustine and Obinutuzumab (BO) in Previously Untreated MCL Using the Lugano Classification for Response in Lymphoma
Complete Response
|
15 Participants
|
|
Determine Objective Response Rates (CR + PR) With Induction Bendamustine and Obinutuzumab (BO) in Previously Untreated MCL Using the Lugano Classification for Response in Lymphoma
Partial Response
|
4 Participants
|
|
Determine Objective Response Rates (CR + PR) With Induction Bendamustine and Obinutuzumab (BO) in Previously Untreated MCL Using the Lugano Classification for Response in Lymphoma
Overall Objective Response
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsFor a given participant, OS will be measured from C1D1 of the induction chemoimmunotherapy to the day the subject dies. Survival times of subjects who are still alive at the end of the follow-up period will be censored. OS will be summarized using point estimate of the median OS, along with the 95% confidence interval.
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Overall Survival (OS)
2-year Overall Survival
|
75.4 percent participants
Interval 50.6 to 89.0
|
|
Overall Survival (OS)
3-year Overall Survival
|
60.9 percent participants
Interval 33.9 to 79.7
|
SECONDARY outcome
Timeframe: Up to 25 months (until 30 days after completion of final dose of study-related treatment)Count of toxicities from the initiation of study treatment until 30 days following the last administration of study treatment or study discontinuation/termination; after this period, only serious adverse events (SAEs) that are possibly, probably, or definitely attributed will be reported. For a given subject, toxicities will be assessed from the time of C1D1 of study therapy until 30 days after completion of final dose of study-related treatment.
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 During Therapy Induction BO Chemoimmunotherapy and Obinutuzumab Consolidation and Maintenance
|
21 Participants
|
POST_HOC outcome
Timeframe: Up to 3 yearsFor each patient, progression-free survival (PFS) will be measured from C1D1 of induction chemoimmunotherapy to the day patient experiences an event of disease progression or death, whichever occurs first. If a patient has not experienced an event at the time of analysis, patient's data will be censored at the date of the last available evaluation. The 3-year PFS probability will be estimated using the Kaplan-Meier method. From the date of C1D1 of induction therapy to the date of progression or death; in the absence of progression or death, subjects will be followed for a minimum of 24 months after completion of study-related treatment. PFS rates at 3 years are reported here.
Outcome measures
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 Participants
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
|
|---|---|
|
Progression Free Survival (PFS) at 3 Years
|
58.7 percent participants
Interval 33.2 to 77.3
|
Adverse Events
Bendamustine + Obinutuzumab (BO)
Serious events: 9 serious events
Other events: 21 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 participants at risk
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
Bendamustine: Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of CLL and for indolent B cell NHLs progressing during or within 6 months of rituximab or a rituximab - containing regimen.
Obinutuzumab: Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 mAb.
|
|---|---|
|
Blood and lymphatic system disorders
Atrial fibrillation / flutter
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Cardiac disorders
Myocardial infarction
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Colitis / Abdominal Infection
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
General disorders
Infusion related reaction
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Immune system disorders
Allergic reaction
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • Number of events 3 • up to 36 months
|
|
Investigations
Thrombocytopenia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Investigations
Neutropenia
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
19.0%
4/21 • Number of events 6 • up to 36 months
|
|
Reproductive system and breast disorders
Genital Edema
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
Other adverse events
| Measure |
Bendamustine + Obinutuzumab (BO)
n=21 participants at risk
Induction chemoimmunotherapy (28 day cycles):
Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles
Obinutuzumab:
* Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15
* Cycles 2-6: 1000 mg IV day 1
Consolidation phase:
Obinutuzumab 1000 mg IV weekly X 4 doses
Maintenance phase (8 week cycles):
Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
Bendamustine: Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of CLL and for indolent B cell NHLs progressing during or within 6 months of rituximab or a rituximab - containing regimen.
Obinutuzumab: Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 mAb.
|
|---|---|
|
General disorders
Flu like symptoms
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
33.3%
7/21 • Number of events 15 • up to 36 months
|
|
General disorders
Localized edema
|
9.5%
2/21 • Number of events 3 • up to 36 months
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
General disorders
Pain
|
19.0%
4/21 • Number of events 6 • up to 36 months
|
|
Immune system disorders
Cytokine release syndrome
|
9.5%
2/21 • Number of events 4 • up to 36 months
|
|
Infections and infestations
Fever
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.8%
1/21 • Number of events 3 • up to 36 months
|
|
Infections and infestations
Soft tissue infection
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Tooth infection
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Urinary tract infection
|
14.3%
3/21 • Number of events 3 • up to 36 months
|
|
Infections and infestations
Vaginal infection
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
3/21 • Number of events 3 • up to 36 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21 • Number of events 4 • up to 36 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.8%
1/21 • Number of events 7 • up to 36 months
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • Number of events 3 • up to 36 months
|
|
Investigations
Investigations - Other, specify
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Investigations
Lymphocyte count decreased
|
42.9%
9/21 • Number of events 35 • up to 36 months
|
|
Investigations
Neutrophil count decreased
|
47.6%
10/21 • Number of events 28 • up to 36 months
|
|
Investigations
Platelet count decreased
|
28.6%
6/21 • Number of events 8 • up to 36 months
|
|
Investigations
Weight gain
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Investigations
Weight loss
|
9.5%
2/21 • Number of events 4 • up to 36 months
|
|
Investigations
White blood cell decreased
|
47.6%
10/21 • Number of events 33 • up to 36 months
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
4/21 • Number of events 5 • up to 36 months
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
3/21 • Number of events 9 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
4.8%
1/21 • Number of events 3 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
19.0%
4/21 • Number of events 10 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
3/21 • Number of events 5 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Vascular disorders
Hypertension
|
23.8%
5/21 • Number of events 11 • up to 36 months
|
|
Vascular disorders
Hypotension
|
14.3%
3/21 • Number of events 3 • up to 36 months
|
|
Vascular disorders
Phlebitis
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Vascular disorders
Thromboembolic event
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
14.3%
3/21 • Number of events 4 • up to 36 months
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 4 • up to 36 months
|
|
Nervous system disorders
Dysgeusia
|
23.8%
5/21 • Number of events 5 • up to 36 months
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
2/21 • Number of events 3 • up to 36 months
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Renal and urinary disorders
Dysuria
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
6/21 • Number of events 8 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Number of events 4 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
19.0%
4/21 • Number of events 4 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
28.6%
6/21 • Number of events 7 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
6/21 • Number of events 11 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.5%
2/21 • Number of events 4 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
3/21 • Number of events 3 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
14.3%
3/21 • Number of events 3 • up to 36 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Vascular disorders
Flushing
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Blood and lymphatic system disorders
Anemia
|
19.0%
4/21 • Number of events 10 • up to 36 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Eye disorders
Eye disorders - Other, specify
|
9.5%
2/21 • Number of events 2 • up to 36 months
|
|
Eye disorders
Dry eye
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Colitis
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
7/21 • Number of events 11 • up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
47.6%
10/21 • Number of events 15 • up to 36 months
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
3/21 • Number of events 3 • up to 36 months
|
|
Gastrointestinal disorders
Dyspepsia
|
19.0%
4/21 • Number of events 6 • up to 36 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21 • Number of events 2 • up to 36 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
9.5%
2/21 • Number of events 4 • up to 36 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Mucositis oral
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
57.1%
12/21 • Number of events 23 • up to 36 months
|
|
Gastrointestinal disorders
Rectal pain
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Number of events 8 • up to 36 months
|
|
General disorders
Chills
|
4.8%
1/21 • Number of events 1 • up to 36 months
|
|
General disorders
Edema limbs
|
14.3%
3/21 • Number of events 4 • up to 36 months
|
|
General disorders
Fatigue
|
52.4%
11/21 • Number of events 24 • up to 36 months
|
|
General disorders
Fever
|
19.0%
4/21 • Number of events 5 • up to 36 months
|
Additional Information
Julie Chang, MD
University of Wisconsin Carbone Cancer Center
Phone: (608) 263-9823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place