Trial Outcomes & Findings for Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery (NCT NCT01867606)

Last Updated: 2025-04-01

Results Overview

For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool \[15\] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

up to 25 months

Results posted on

2025-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Patients receive SBI PO BID on days 1-28.\>\> \>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\> \>\> serum-derived bovine immunoglobulin protein isolate: Given PO\>\> \>\> laboratory biomarker analysis: Correlative studies\>\> \>\> quality-of-life assessment: Ancillary studies\>\> \>\> questionnaire administration: Ancillary studies	Arm II (Placebo) Patients receive placebo PO BID on days 1-28.\>\> \>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\> \>\> placebo: Given PO\>\> \>\> laboratory biomarker analysis: Correlative studies\>\> \>\> quality-of-life assessment: Ancillary studies\>\> \>\> questionnaire administration: Ancillary studies
Overall Study STARTED	26	32
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	10	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Patients receive SBI PO BID on days 1-28.\>\> \>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\> \>\> serum-derived bovine immunoglobulin protein isolate: Given PO\>\> \>\> laboratory biomarker analysis: Correlative studies\>\> \>\> quality-of-life assessment: Ancillary studies\>\> \>\> questionnaire administration: Ancillary studies	Arm II (Placebo) Patients receive placebo PO BID on days 1-28.\>\> \>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\> \>\> placebo: Given PO\>\> \>\> laboratory biomarker analysis: Correlative studies\>\> \>\> quality-of-life assessment: Ancillary studies\>\> \>\> questionnaire administration: Ancillary studies
Overall Study Withdrawal by Subject	10	14
Overall Study Protocol Violation	0	1

Baseline Characteristics

Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm II (Placebo) n=32 Participants Patients receive placebo PO BID on days 1-28.\>\> \>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\> \>\> placebo: Given PO\>\> \>\> laboratory biomarker analysis: Correlative studies\>\> \>\> quality-of-life assessment: Ancillary studies\>\> \>\> questionnaire administration: Ancillary studies	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=26 Participants Patients receive SBI PO BID on days 1-28.\>\> \>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\> \>\> serum-derived bovine immunoglobulin protein isolate: Given PO\>\> \>\> laboratory biomarker analysis: Correlative studies\>\> \>\> quality-of-life assessment: Ancillary studies\>\> \>\> questionnaire administration: Ancillary studies	Total n=58 Participants Total of all reporting groups
Age, Continuous	62 Years n=5 Participants	62 Years n=7 Participants	62 Years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 25 months

Outcome measures

Outcome measures
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=16 Participants Patients receive SBI PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> serum-derived bovine immunoglobulin protein isolate: Given PO	Arm II (Placebo) n=17 Participants Patients receive placebo PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> placebo: Given PO
Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool	4.86 Months Interval 3.0 to 6.43	3.29 Months Interval 2.43 to 10.43

SECONDARY outcome

Timeframe: up to 25 months

Population: All evaluable patients

Frequency tables will be reviewed to determine adverse event patterns, this data is reported in the adverse events section of this report. Below is the number of patients that experienced an adverse event greater than or equal to 2.

Outcome measures

Outcome measures
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=16 Participants Patients receive SBI PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> serum-derived bovine immunoglobulin protein isolate: Given PO	Arm II (Placebo) n=17 Participants Patients receive placebo PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> placebo: Given PO
Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0	5 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 1 month post-surgery

Population: All evaluable patients

Compared between the 2 arms using Chi-Square or Fisher's Exact tests.

Outcome measures

Outcome measures
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=16 Participants Patients receive SBI PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> serum-derived bovine immunoglobulin protein isolate: Given PO	Arm II (Placebo) n=17 Participants Patients receive placebo PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> placebo: Given PO
Surgical Complication Rates Severe Complication	3 Participants	3 Participants
Surgical Complication Rates Moderate Complication	2 Participants	7 Participants
Surgical Complication Rates Mild Complication	10 Participants	6 Participants
Surgical Complication Rates No Complication	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 25 months

The frequency and percentage for each Compliance Questionnaire category will be summarized descriptively by cycle and by intervention arm. In addition, cycle by cycle compliance data will be compared between the 2 arms using a Chi-square test.

Outcome measures

Outcome measures
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=16 Participants Patients receive SBI PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> serum-derived bovine immunoglobulin protein isolate: Given PO	Arm II (Placebo) n=17 Participants Patients receive placebo PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> placebo: Given PO
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 1 · Patient off treatment (NA)	0 Participants	0 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 1 · Always to Usually Compliant	8 Participants	13 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 1 · Occasionally to Never Compliant	5 Participants	4 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 1 · Missing	3 Participants	0 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 2 · Always to Usually Compliant	3 Participants	7 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 2 · Occasionally to Never Compliant	1 Participants	0 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 2 · Missing	0 Participants	1 Participants
Intervention Compliance Assessed Using the Compliance Questionnaire Cycle 2 · Patient off treatment (NA)	12 Participants	9 Participants

SECONDARY outcome

Timeframe: up to 25 months

Population: All evaluable patients

All 14 of the individual items from the PQL tool, along with the 4 additional items after the PQL questions will be analyzed and compared between the 2 intervention arms. Differences between post-randomization and baseline QOL scores will be analyzed and compared between the 2 arms using a Wilcoxon Rank-sum test. Also, other graphical and statistical methods will be used to compare the QOL between the 2 arms over time. For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.

Outcome measures

Outcome measures
Measure	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=16 Participants Patients receive SBI PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> serum-derived bovine immunoglobulin protein isolate: Given PO	Arm II (Placebo) n=17 Participants Patients receive placebo PO BID on days 1-28. \> \> \> \> \> \> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. \> \> \> \> \> \> placebo: Given PO
Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale Improvement	11 Participants	13 Participants
Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale No Improvement	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to 25 months

Population: All evaluable patients who never started intervention or discontinue early. All patients completed the study, no patients are evaluable for this outcome.

Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.

Outcome measures

Outcome data not reported

Adverse Events

Arm II (Placebo)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm II (Placebo) n=16 participants at risk questionnaire administration: Ancillary studies	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=18 participants at risk questionnaire administration: Ancillary studies
Blood and lymphatic system disorders Anemia	0.00% 0/16 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Abdominal pain	12.5% 2/16 • Number of events 2 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Ileus	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Nausea	12.5% 2/16 • Number of events 2 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Small intestinal obstruction	18.8% 3/16 • Number of events 3 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Vomiting	12.5% 2/16 • Number of events 2 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
General disorders Fatigue	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Infections and infestations Urinary tract infection	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Investigations Platelet count decreased	0.00% 0/16 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/16 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Metabolism and nutrition disorders Hyponatremia	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Vascular disorders Thromboembolic event	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.

Other adverse events

Other adverse events
Measure	Arm II (Placebo) n=16 participants at risk questionnaire administration: Ancillary studies	Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) n=18 participants at risk questionnaire administration: Ancillary studies
Gastrointestinal disorders Abdominal pain	56.2% 9/16 • Number of events 12 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	38.9% 7/18 • Number of events 16 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Bloating	50.0% 8/16 • Number of events 12 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	22.2% 4/18 • Number of events 7 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Diarrhea	25.0% 4/16 • Number of events 6 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	22.2% 4/18 • Number of events 6 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Flatulence	37.5% 6/16 • Number of events 7 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	50.0% 9/18 • Number of events 21 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Nausea	43.8% 7/16 • Number of events 8 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	44.4% 8/18 • Number of events 12 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Gastrointestinal disorders Vomiting	25.0% 4/16 • Number of events 4 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	27.8% 5/18 • Number of events 5 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
General disorders Fatigue	75.0% 12/16 • Number of events 20 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	77.8% 14/18 • Number of events 31 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Infections and infestations Wound infection	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Injury, poisoning and procedural complications Wound complication	6.2% 1/16 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	0.00% 0/18 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/16 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.	5.6% 1/18 • Number of events 1 • Up to 25 months The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.

Additional Information

Aminah Jatoi, M.D.

Mayo Clinic

Phone: (507) 284-4918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place