Trial Outcomes & Findings for Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment (NCT NCT03505762)

Last Updated: 2026-08-11

Results Overview

Will use the Kaplan Meier method to estimate the cumulative percentage of patients with hyperglycemia, and the log-rank test to compare hyperglycemia rates by arm after 3 cycles of R-CHOP chemotherapy.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

After course 3 (63 days)

Results posted on

2026-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Tailored Prednisone Dose) Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Overall Study STARTED	40	40
Overall Study COMPLETED	33	28
Overall Study NOT COMPLETED	7	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Tailored Prednisone Dose) Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Overall Study Adverse Event	1	1
Overall Study Death	0	2
Overall Study Withdrawal by Subject	3	3
Overall Study Physician Decision	2	5
Overall Study consented but not treated	1	1

Baseline Characteristics

Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Tailored Prednisone Dose) n=40 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=40 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=54 Participants	19 Participants n=54 Participants	38 Participants n=27 Participants
Age, Categorical >=65 years	21 Participants n=54 Participants	21 Participants n=54 Participants	42 Participants n=27 Participants
Age, Continuous	65 years n=54 Participants	65 years n=54 Participants	65 years n=27 Participants
Sex: Female, Male Female	21 Participants n=54 Participants	19 Participants n=54 Participants	40 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=54 Participants	21 Participants n=54 Participants	40 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=54 Participants	0 Participants n=54 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants	1 Participants n=54 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=54 Participants	4 Participants n=54 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	37 Participants n=54 Participants	35 Participants n=54 Participants	72 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=27 Participants
Region of Enrollment United States	40 participants n=54 Participants	40 participants n=54 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: After course 3 (63 days)

Population: Missing data for 3 patients - off study prior to data collection

Outcome measures

Outcome measures
Measure	Arm I (Tailored Prednisone Dose) n=38 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=39 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Cumulative Percentage of Patients With Hyperglycemia Patients of Standard or Tailored Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate and Prednisone (R-CHOP)	39.4 percent of patients with hyperglycemia	36.8 percent of patients with hyperglycemia

SECONDARY outcome

Timeframe: from baseline through 6 cycles (126 days) and at 6 months after completion of chemotherapy

Will use the Kaplan Meier method to estimate the cumulative incidence of hyperglycemia, and the log-rank test to compare hyperglycemia incidence by arm after 6 cycles and after 6 months (up to 400 days from start of treatment) of R-CHOP chemotherapy.

Outcome measures

Outcome measures
Measure	Arm I (Tailored Prednisone Dose) n=38 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=39 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Cumulative Incidence of Hyperglycemia of Standard or Tailored R-CHOP Through 6 cycles	42.4 percent with hyperglycemia	43.8 percent with hyperglycemia
Cumulative Incidence of Hyperglycemia of Standard or Tailored R-CHOP Through the 6 month post treatment visits	42.4 percent with hyperglycemia	43.8 percent with hyperglycemia

SECONDARY outcome

Timeframe: After course 6 (126 days)

Population: Due to early trial exit or non-treatment, response was not measured on the full cohort after cycle 3 or after cycle 6 leading to some missing data.

Will use a Fisher's exact test to compare response rates (complete response) through 6 cycles of R-CHOP by arm. Response is determined by Cheson's criteria.

Outcome measures

Outcome measures
Measure	Arm I (Tailored Prednisone Dose) n=37 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=34 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Response Rates of Standard or Tailored R-CHOP as Measured by Cheson's Criteria	32 Participants	30 Participants

SECONDARY outcome

Timeframe: Up to 6 months (up to 400 days from start of treatment)

Population: 2 patients were untreated and therefore do not have adverse events available during or post treatment

Will compare the rates of the incidence of grade III and higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE) criteria by arm of R-CHOP for each cycle using Fisher's exact tests.

Outcome measures

Outcome measures
Measure	Arm I (Tailored Prednisone Dose) n=39 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=39 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Rates of Grade III or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE) Criteria From Standard or Tailored R-CHOP	32 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to course 6 (126 days)

Population: 2 patients were enrolled but no treated and therefore have no data for this questionnaire. Not all participants responded to all of the PRO-CTCAE questions, some preferred not to answer, leaving a few cases of missing data.

Compare the worst severity of PRO-CTCAE assessments by arm of R-CHOP using two group t-tests. The questionnaire was completed at each cycle (1-6) and the worst response for each participant for each measure was calculated for comparison. Severity for each measure was captured on a 5 point scale with 1=None and 5=Very severe.

Outcome measures

Outcome measures
Measure	Arm I (Tailored Prednisone Dose) n=39 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=39 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Memory	2.2 score on a scale Standard Deviation 0.8	2.0 score on a scale Standard Deviation 0.8
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Dry Mouth	2.7 score on a scale Standard Deviation 1.1	2.7 score on a scale Standard Deviation 1.1
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Nausea	2.2 score on a scale Standard Deviation 1.1	2.1 score on a scale Standard Deviation 1.0
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Vomiting	1.4 score on a scale Standard Deviation 0.8	1.3 score on a scale Standard Deviation 0.5
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Heartburn	2.3 score on a scale Standard Deviation 0.9	2.1 score on a scale Standard Deviation 0.9
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Constipation	2.3 score on a scale Standard Deviation 1.1	2.6 score on a scale Standard Deviation 1.2
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Numbness	2.4 score on a scale Standard Deviation 1.2	2.2 score on a scale Standard Deviation 0.9
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Concentration	2.3 score on a scale Standard Deviation 0.9	2.2 score on a scale Standard Deviation 0.8
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Insomnia	2.8 score on a scale Standard Deviation 1.3	2.7 score on a scale Standard Deviation 0.9
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE Fatigue	3.2 score on a scale Standard Deviation 1.1	3.2 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Day 1 of cycles 1, 4, 6, and 6 months post treatment (up to 400 days from start of treatment)

Population: Two untreated patients are missing. Other missing data is due to patient dropout or not completing the form.

Evaluated using the Functional Assessment of Cancer Therapy (FACT)-Lymphoma, FACT Gynecologic Oncology Group (GOG)-Neurotoxicity (nxt) additional concerns and Patient-Reported Outcomes Measurement Information System 29. Will compare the HRQOL measures between arms receiving R-CHOP chemotherapy using two group t-tests at each time point of interest (day 1 of cycles 1, and 4, after cycle 6, and 6 months post treatment (up to 400 days from start of treatment)). Measures reported are the total FACT-lymphoma score ranging from 0-168 and the FACT-GOG neurotoxicity subscale ranging from 0-16. For both measures higher values indicate of better health related quality of life.

Outcome measures

Outcome measures
Measure	Arm I (Tailored Prednisone Dose) n=39 Participants Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=39 Participants Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Health Related Quality of Life (HRQOL) Scores FACT-Lym total cycle 1	103.4 score on a scale Standard Deviation 20.8	111.8 score on a scale Standard Deviation 15.9
Health Related Quality of Life (HRQOL) Scores FACT-Lym total cycle 4	112.9 score on a scale Standard Deviation 16.9	116.5 score on a scale Standard Deviation 12.9
Health Related Quality of Life (HRQOL) Scores FACT-Lym total after cycle 6	115.7 score on a scale Standard Deviation 18.2	117.6 score on a scale Standard Deviation 15.8
Health Related Quality of Life (HRQOL) Scores FACT-Lym total 6 months post treatment	121.4 score on a scale Standard Deviation 15.1	122.0 score on a scale Standard Deviation 16.6
Health Related Quality of Life (HRQOL) Scores FACT-GOG nxt subscale cycle 1	14.0 score on a scale Standard Deviation 3.0	14.0 score on a scale Standard Deviation 3.3
Health Related Quality of Life (HRQOL) Scores FACT-GOG nxt subscale cycle 4	12.8 score on a scale Standard Deviation 3.7	13.3 score on a scale Standard Deviation 3.1
Health Related Quality of Life (HRQOL) Scores FACT-GOG nxt subscale after cycle 6	12.0 score on a scale Standard Deviation 4.4	13.3 score on a scale Standard Deviation 3.1
Health Related Quality of Life (HRQOL) Scores FACT-GOG nxt subscale 6 months post treatment	12.3 score on a scale Standard Deviation 4.6	13.7 score on a scale Standard Deviation 3.1

Adverse Events

Arm I (Tailored Prednisone Dose)

Serious events: 10 serious events

Other events: 39 other events

Deaths: 7 deaths

Arm II (Usual Care Prednisone Dose)

Serious events: 11 serious events

Other events: 39 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Tailored Prednisone Dose) n=39 participants at risk Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV	Arm II (Usual Care Prednisone Dose) n=39 participants at risk Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Quality-of-Life Assessment: Ancillary correlative Questionnaire Administration: Ancillary studies Rituximab: Given IV Vincristine Sulfate: Given IV
Blood and lymphatic system disorders Febrile neutropenia	5.1% 2/39 • Number of events 3 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	7.7% 3/39 • Number of events 4 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Infections and infestations Sepsis	5.1% 2/39 • Number of events 2 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Infections and infestations Skin infection	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Investigations Lymphocyte count decreased	5.1% 2/39 • Number of events 4 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Investigations Neutrophil count decreased	15.4% 6/39 • Number of events 7 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	12.8% 5/39 • Number of events 7 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Investigations Platelet count decreased	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 3 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Investigations White blood cell decreased	12.8% 5/39 • Number of events 8 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	12.8% 5/39 • Number of events 8 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Nervous system disorders Paresthesia	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Nervous system disorders Syncope	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Cardiac disorders Atrial fibrillation	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Gastrointestinal disorders Gastrointestinal disorders - Other: Bowel perforation	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 2 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.
Gastrointestinal disorders Vomiting	0.00% 0/39 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.	2.6% 1/39 • Number of events 1 • Adverse events were monitored for the duration of each treatment cycle. Duration of adverse event monitoring had an average of 3 months and a maximum of 6 months. All cause mortality is monitored for up to 5 years from enrollment date with a median follow-up time of 54 months.

Other adverse events

Additional Information

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 3367135440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place