Trial Outcomes & Findings for Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ (NCT NCT00555152)
NCT ID: NCT00555152
Last Updated: 2018-04-20
Results Overview
Reduction in percent of Ki67 positive cells at surgery compared to baseline as a function of treatment. Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant. Proliferation will be assessed by immunohistochemical (IHC) staining for Ki67, and the change in percentage of Ki67 positive cells will be compared in lapatinib-treated samples versus placebo.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
2-6 weeks from baseline to surgery, up to 6 weeks
Results posted on
2018-04-20
Participant Flow
Activated 1/17/2008 at Baylor College of Medicine (BCM), MD Anderson Cancer Center, Dana-Farber Cancer Institute, Mayo Clinic, Georgetown University \& Walter Reed Army Medical Center; closed at BCM 3/8/2010, re-activated 9/19/2011 at MD Anderson, Dana-Farber Cancer Institute, Mayo Clinic \& University of Alabama, Birmingham, closed 8/28/2014.
A total of 22 participants were enrolled and randomized to 3 of 4 treatment arms; Two of the 4 initial arms were removed in the second period with one of those having no enrollment. Three participants were enrolled while the study was open at BCM, the other 19 were enrolled after the study was transferred to MD Anderson (second study period).
Participant milestones
| Measure |
Arm I Lapatinib 1500 mg
Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm II Lapatinib 1000 mg
Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm III Lapatinib 750 mg
Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm IV Placebo
Placebo orally once daily for 2-6 weeks until the time of surgery.
|
|---|---|---|---|---|
|
Period Open at BCM: 1/17/08-3/8/10
STARTED
|
2
|
0
|
0
|
1
|
|
Period Open at BCM: 1/17/08-3/8/10
COMPLETED
|
2
|
0
|
0
|
1
|
|
Period Open at BCM: 1/17/08-3/8/10
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Transfer to MD Anderson: 9/19/11-8/28/14
STARTED
|
0
|
10
|
0
|
9
|
|
Transfer to MD Anderson: 9/19/11-8/28/14
COMPLETED
|
0
|
10
|
0
|
9
|
|
Transfer to MD Anderson: 9/19/11-8/28/14
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ
Baseline characteristics by cohort
| Measure |
Arm I Lapatinib 1500 mg
n=2 Participants
Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm II Lapatinib 1000 mg
n=10 Participants
Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm III Lapatinib 750 mg
Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm IV Placebo
n=10 Participants
Placebo orally once daily for 2-6 weeks until the time of surgery.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
—
|
52 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
51.3 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
—
|
10 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
—
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
—
|
9 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
10 participants
n=7 Participants
|
—
|
10 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2-6 weeks from baseline to surgery, up to 6 weeksPopulation: No outcome data available due to laboratory issues affecting the analysis of biomarkers results.
Reduction in percent of Ki67 positive cells at surgery compared to baseline as a function of treatment. Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant. Proliferation will be assessed by immunohistochemical (IHC) staining for Ki67, and the change in percentage of Ki67 positive cells will be compared in lapatinib-treated samples versus placebo.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From baseline to 4-5 weeks after surgeryToxicity profile summarized reflects incidence by number of participants affected with adverse events by Maximum Grade 1 to 3, additional adverse event according to the NCI CTCAE version 3.0 reported in Adverse Event section results.
Outcome measures
| Measure |
Arm I Lapatinib 1500 mg
n=2 Participants
Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm II Lapatinib 1000 mg
n=10 Participants
Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm III Lapatinib 750 mg
Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm IV Placebo
n=10 Participants
Placebo orally once daily for 2-6 weeks until the time of surgery.
|
|---|---|---|---|---|
|
Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0
Grade 3
|
0 participants
|
0 participants
|
—
|
1 participants
|
|
Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0
Grade 2
|
2 participants
|
6 participants
|
—
|
3 participants
|
|
Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0
Grade 1
|
0 participants
|
3 participants
|
—
|
4 participants
|
SECONDARY outcome
Timeframe: 2-6 weeks from baseline to surgery, up to 6 weeksPopulation: DCIS was present at the time of surgery in all patients.
Number of participants with DCIS incidence on surgical excision. Differences in histologic response (disappearance of DCIS) will be evaluated using Fisher's exact test. Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.
Outcome measures
| Measure |
Arm I Lapatinib 1500 mg
n=2 Participants
Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm II Lapatinib 1000 mg
n=10 Participants
Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm III Lapatinib 750 mg
Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm IV Placebo
n=10 Participants
Placebo orally once daily for 2-6 weeks until the time of surgery.
|
|---|---|---|---|---|
|
Incidence of Ductal Carcinoma in Situ Remaining at Resection
Present
|
2 participants
|
10 participants
|
—
|
10 participants
|
|
Incidence of Ductal Carcinoma in Situ Remaining at Resection
Absent
|
0 participants
|
0 participants
|
—
|
0 participants
|
SECONDARY outcome
Timeframe: 2-6 weeks from baseline to surgery, Up to 6 weeksPopulation: No outcome data available due to laboratory issues affecting the analysis of biomarkers results.
Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.
Outcome measures
Outcome data not reported
Adverse Events
Arm I Lapatinib 1500 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II Lapatinib 1000 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm III Lapatinib 750 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm IV Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I Lapatinib 1500 mg
n=2 participants at risk
Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm II Lapatinib 1000 mg
n=10 participants at risk
Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm III Lapatinib 750 mg
Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm IV Placebo
n=10 participants at risk
Placebo orally once daily for 2-6 weeks until the time of surgery.
|
|---|---|---|---|---|
|
Vascular disorders
Hematoma
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
Other adverse events
| Measure |
Arm I Lapatinib 1500 mg
n=2 participants at risk
Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm II Lapatinib 1000 mg
n=10 participants at risk
Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm III Lapatinib 750 mg
Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
|
Arm IV Placebo
n=10 participants at risk
Placebo orally once daily for 2-6 weeks until the time of surgery.
|
|---|---|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
General disorders
Constitutional Symptoms
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
General disorders
Insomnia
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
30.0%
3/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
30.0%
3/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
30.0%
3/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Endocrine disorders
Hot flashes/flushes
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
70.0%
7/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) Oral cavity
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
40.0%
4/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Vascular disorders
Hemorrhage, GI Rectum
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Vascular disorders
Hemorrhage, GU Vagina
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory Nose
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Vascular disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Blood and lymphatic system disorders
Lymphatics
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
General disorders
Pain
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
30.0%
3/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
General disorders
Pain -Other
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
20.0%
2/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Renal and urinary disorders
Bladder spasms
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Renal and urinary disorders
Renal/Genitourinary
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
|
Injury, poisoning and procedural complications
Cytokine release syndrome/acute infusion reaction
|
0.00%
0/2 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
0.00%
0/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
—
0/0 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
10.0%
1/10 • Subjects followed up to 4-5 weeks after surgery to assess for adverse events with overall collection period approximately five years, first study period January 2008 to March 2010 and second September 2011 to August 2014.
|
Additional Information
Powel H. Brown, MD/Chair, Clinical Cancer Prevention
University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60