Trial Outcomes & Findings for Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer (NCT NCT01226979)
NCT ID: NCT01226979
Last Updated: 2025-02-28
Results Overview
Those participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
High-dose Endorectal Brachytherapy (HDRBT)
The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
Daily dose of 6.5 Gy over four consecutive days
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|---|---|
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Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
Baseline characteristics by cohort
| Measure |
HDRBT
n=16 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
High-dose endorectal brachytherapy: The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
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|---|---|
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Age, Continuous
|
53.2 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThose participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.
Outcome measures
| Measure |
HDRBT (High Dose Rectal Brachytherapy)
n=16 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
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|---|---|
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Number of Participants With Pathologic Complete Response
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5 Participants
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SECONDARY outcome
Timeframe: 3 to 6 weeks post-treatmentPopulation: One patient had to go into surgery and it was not possible to do the imaging necessary for this assessment.
Radiographic measurements of pelvic MRI and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT imaging will be used to classify patients as responders or non-responders to HDRBT using standard RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECISTv1.0) is defined as follows: Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.
Outcome measures
| Measure |
HDRBT (High Dose Rectal Brachytherapy)
n=15 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
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|---|---|
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Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy
Complete Response
|
1 Participants
|
|
Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy
Partial response
|
13 Participants
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|
Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy
Progressive disease
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0 Participants
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Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy
Stable disease
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1 Participants
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SECONDARY outcome
Timeframe: Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 weeks post-op, every 4 months for 2 years and every 6 months for years 3 and 4Population: Not all participants could be assessed at all the time points therefore data was not collected for some participants at some points as shown by participants for those time points being less than 16.
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 form is a self-assessment completed by patients which examines current symptoms and functionality. Total score ranges from 0 to 100, a higher score represents a higher ("better") quality of life.
Outcome measures
| Measure |
HDRBT (High Dose Rectal Brachytherapy)
n=16 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
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|---|---|
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
Pre-HDRBT
|
47.5 score on a scale
Standard Deviation 8.53
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|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
During HDRBT
|
50 score on a scale
Standard Deviation 12.45
|
|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
1 week Post-HDRBT Treatment
|
52.23 score on a scale
Standard Deviation 7.2
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|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
2 Weeks Post-HDRBT Treatment
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64.33 score on a scale
Standard Deviation 10.69
|
|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
3-6 weeks Post-HDRBT Treatment
|
62.03 score on a scale
Standard Deviation 13.09
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
3-6 weeks post-op
|
59.27 score on a scale
Standard Deviation 8.9
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
4 Months post-op
|
60.4 score on a scale
Standard Deviation 13.11
|
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
8 Months post-op
|
53 score on a scale
Standard Deviation 8.28
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|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
12 Months post-op
|
54 score on a scale
Standard Deviation 9.48
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
16 Months post-op
|
49.89 score on a scale
Standard Deviation 12.54
|
|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
20 Months post-op
|
52.11 score on a scale
Standard Deviation 6.27
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|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
24 Months post-op
|
56.5 score on a scale
Standard Deviation 15.96
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
30 Months post-op
|
54.29 score on a scale
Standard Deviation 13
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
36 Months post-op
|
56.5 score on a scale
Standard Deviation 10.3
|
|
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
42 Months post-op
|
59.5 score on a scale
Standard Deviation 7.23
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Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
48 Months post-op
|
53.75 score on a scale
Standard Deviation 13.45
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SECONDARY outcome
Timeframe: Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4Population: Not all participants could be assessed at all the time points therefore data was not collected for some participants at some points as shown by participants for those time points being less than 16.
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-CR38 form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score range is from 38-152. A higher score represents better quality of life.
Outcome measures
| Measure |
HDRBT (High Dose Rectal Brachytherapy)
n=16 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
|
|---|---|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
Pre-HDRBT
|
40.63 score on a scale
Standard Deviation 7.37
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
During HDRBT
|
36.8 score on a scale
Standard Deviation 8.77
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
1 week Post-HDRBT Treatment
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42.08 score on a scale
Standard Deviation 11.24
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Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
2 Weeks Post-HDRBT Treatment
|
42 score on a scale
Standard Deviation 8.19
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
weeks 3-6 Post-HDRBT Treatment
|
48.72 score on a scale
Standard Deviation 17.62
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
3-6 weeks post-op
|
47.8 score on a scale
Standard Deviation 12.14
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
4 Months post-op
|
45.6 score on a scale
Standard Deviation 4.34
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
8 Months post-op
|
50 score on a scale
Standard Deviation 7.78
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
12 Months post-op
|
43.6 score on a scale
Standard Deviation 11.53
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
16 Months post-op
|
47.67 score on a scale
Standard Deviation 5.12
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
20 Months post-op
|
45 score on a scale
Standard Deviation 6.54
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
24 Months post-op
|
47.3 score on a scale
Standard Deviation 9.74
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
30 Months post-op
|
38.86 score on a scale
Standard Deviation 20.76
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
36 Months post-op
|
49.75 score on a scale
Standard Deviation 10.47
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
42 Months post-op
|
46 score on a scale
Standard Deviation 2.16
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|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
48 Months post-op
|
38.75 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4Population: Not all participants could be assessed at all the time points therefore data was not collected for some participants at some points as shown by participants for those time points being less than 16.
The European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score ranges from 29 - 116. A higher score represents better quality of life.
Outcome measures
| Measure |
HDRBT (High Dose Rectal Brachytherapy)
n=16 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
|
|---|---|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
Pre-HDRBT
|
34.56 score on a scale
Standard Deviation 6.03
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
During HDRBT
|
32.3 score on a scale
Standard Deviation 5.27
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
1 week Post-HDRBT Treatment
|
37.46 score on a scale
Standard Deviation 9.91
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
2 Weeks Post-HDRBT Treatment
|
34 score on a scale
Standard Deviation 11.53
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
3-6 weeks Post-HDRBT Treatment
|
41.78 score on a scale
Standard Deviation 14.62
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
3-6 weeks post-op
|
42.6 score on a scale
Standard Deviation 10.47
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
4 Months post-op
|
42.2 score on a scale
Standard Deviation 3.96
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
8 Months post-op
|
43 score on a scale
Standard Deviation 6.82
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
12 Months post-op
|
42 score on a scale
Standard Deviation 6.78
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
16 Months post-op
|
41.22 score on a scale
Standard Deviation 5.36
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
20 Months post-op
|
35.56 score on a scale
Standard Deviation 6.78
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
24 Months post-op
|
40.2 score on a scale
Standard Deviation 11.56
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
30 Months post-op
|
39.71 score on a scale
Standard Deviation 12.72
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
36 Months post-op
|
43.5 score on a scale
Standard Deviation 6.95
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
42 Months post-op
|
38.5 score on a scale
Standard Deviation 6.56
|
|
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
48 Months post-op
|
30.75 score on a scale
Standard Deviation 8.18
|
SECONDARY outcome
Timeframe: 3-6 weeksAcute gastrointestinal toxicity will be assessed using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). CTCAE v4.0 ratings of 3 or 4 (seriousness of 17%) adverse events will be assessed and reported.
Outcome measures
| Measure |
HDRBT (High Dose Rectal Brachytherapy)
n=16 Participants
Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
High-dose endorectal brachytherapy (HDRBT): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
|
|---|---|
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Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0
Grade 3 pain
|
2 Participants
|
|
Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0
Grade 3 Proctitis
|
1 Participants
|
Adverse Events
High-Dose-Rate Endorectal Brachytherapy (HDRBT)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-Dose-Rate Endorectal Brachytherapy (HDRBT)
n=16 participants at risk
The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
Daily dose of 6.5 Gy over four consecutive days
|
|---|---|
|
General disorders
Pain
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Proctitis
|
6.2%
1/16 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
High-Dose-Rate Endorectal Brachytherapy (HDRBT)
n=16 participants at risk
The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
Daily dose of 6.5 Gy over four consecutive days
|
|---|---|
|
General disorders
Pain
|
100.0%
16/16 • 2 years
|
|
General disorders
Fatigue
|
100.0%
16/16 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
16/16 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
16/16 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
81.2%
13/16 • 2 years
|
|
Gastrointestinal disorders
Proctitis
|
68.8%
11/16 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
10/16 • 2 years
|
|
Gastrointestinal disorders
Fecal Incontinence
|
62.5%
10/16 • 2 years
|
|
Gastrointestinal disorders
GI - hemorrhage
|
62.5%
10/16 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
62.5%
10/16 • 2 years
|
|
Gastrointestinal disorders
Rectal pain
|
62.5%
10/16 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
56.2%
9/16 • 2 years
|
|
Blood and lymphatic system disorders
WBC count decreased
|
56.2%
9/16 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
8/16 • 2 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
50.0%
8/16 • 2 years
|
|
Metabolism and nutrition disorders
ALT increase
|
43.8%
7/16 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
37.5%
6/16 • 2 years
|
|
Renal and urinary disorders
Nocturia
|
37.5%
6/16 • 2 years
|
|
Renal and urinary disorders
Urinary Frequency/urgency
|
37.5%
6/16 • 2 years
|
|
Renal and urinary disorders
Dysuria
|
31.2%
5/16 • 2 years
|
|
General disorders
Erectile dysfunction
|
25.0%
4/16 • 2 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
25.0%
4/16 • 2 years
|
|
Blood and lymphatic system disorders
Platelet count deceased
|
25.0%
4/16 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
4/16 • 2 years
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
18.8%
3/16 • 2 years
|
|
Metabolism and nutrition disorders
Aspartate Amino Transferase increased
|
18.8%
3/16 • 2 years
|
|
Metabolism and nutrition disorders
AST increased
|
18.8%
3/16 • 2 years
|
|
Blood and lymphatic system disorders
Hyponatremia
|
18.8%
3/16 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
18.8%
3/16 • 2 years
|
|
Metabolism and nutrition disorders
Alanine Amino Transferase Increased
|
12.5%
2/16 • 2 years
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
12.5%
2/16 • 2 years
|
|
Renal and urinary disorders
Incontinence
|
12.5%
2/16 • 2 years
|
|
Gastrointestinal disorders
Rectal Obstruction
|
12.5%
2/16 • 2 years
|
|
Gastrointestinal disorders
Rectal stenosis
|
12.5%
2/16 • 2 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
12.5%
2/16 • 2 years
|
|
General disorders
Vomiting
|
12.5%
2/16 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place