Trial Outcomes & Findings for Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer (NCT NCT02076074)
NCT ID: NCT02076074
Last Updated: 2024-07-11
Results Overview
Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2024-07-11
Participant Flow
Participant milestones
| Measure |
Treatment (HG-PBI)
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsQuantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Free of Serious Treatment Related Toxicity
Number of patients free of acute grade 3 or higher treatment related toxicity
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Who Are Free of Serious Treatment Related Toxicity
Number of patients free of late grade 3 or higher treatment related toxicity
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 5 yearsPercentage of patients without ipsilateral breast tumor recurrences (IBTR).
Outcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 5 yearsIpsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 5 yearsOutcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Free From Distant Metastases
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5Population: If participants did not complete the questionnaire or did not complete a question then they are not included in the number analyzed.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. For the global health and five functional scales (Cognitive Functioning, Emotional Functioning, Physical Functioning, Role Functioning, and Social Functioning) a high score correlates to a high level of functioning or a better outcome. For the three symptom scales and six single item scales (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea, Financial Difficulties) a high score correlates to high levels of symptoms or problems and a worse outcome.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=44 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=49 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
n=49 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
n=44 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
n=48 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
n=42 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
n=35 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
n=33 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Cognitive Functioning
|
-2.27 score on a scale
Standard Deviation 17.46
|
-6.12 score on a scale
Standard Deviation 18.22
|
-6.46 score on a scale
Standard Deviation 16.95
|
-3.9 score on a scale
Standard Deviation 16.74
|
-5.43 score on a scale
Standard Deviation 16.15
|
-5.9 score on a scale
Standard Deviation 13.96
|
-1.59 score on a scale
Standard Deviation 13.17
|
-4.41 score on a scale
Standard Deviation 12.52
|
0.52 score on a scale
Standard Deviation 13.04
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Global Health Status
|
-0.57 score on a scale
Standard Deviation 10.54
|
-0.68 score on a scale
Standard Deviation 8.81
|
-2.89 score on a scale
Standard Deviation 12.68
|
-2.48 score on a scale
Standard Deviation 12.76
|
-4.26 score on a scale
Standard Deviation 17.29
|
-1.39 score on a scale
Standard Deviation 15.21
|
-3.57 score on a scale
Standard Deviation 14.51
|
-3.92 score on a scale
Standard Deviation 17.44
|
-1.3 score on a scale
Standard Deviation 11.99
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Pain
|
-3.03 score on a scale
Standard Deviation 18.42
|
0 score on a scale
Standard Deviation 22.31
|
-2.04 score on a scale
Standard Deviation 20.59
|
-3.26 score on a scale
Standard Deviation 13.89
|
-1.14 score on a scale
Standard Deviation 18.47
|
-1.39 score on a scale
Standard Deviation 17.13
|
-1.59 score on a scale
Standard Deviation 23.52
|
-3.81 score on a scale
Standard Deviation 24.62
|
-0.51 score on a scale
Standard Deviation 23.01
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Appetite Loss
|
-0.78 score on a scale
Standard Deviation 15.41
|
0.68 score on a scale
Standard Deviation 14.42
|
0.69 score on a scale
Standard Deviation 12.84
|
-1.42 score on a scale
Standard Deviation 9.72
|
1.52 score on a scale
Standard Deviation 14.3
|
2.08 score on a scale
Standard Deviation 15.99
|
-0.81 score on a scale
Standard Deviation 11.76
|
-1.9 score on a scale
Standard Deviation 7.85
|
2.02 score on a scale
Standard Deviation 8.08
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Dyspnea
|
-1.55 score on a scale
Standard Deviation 19.18
|
1.36 score on a scale
Standard Deviation 16.61
|
1.36 score on a scale
Standard Deviation 13.54
|
5.67 score on a scale
Standard Deviation 16.03
|
5.3 score on a scale
Standard Deviation 18.94
|
8.33 score on a scale
Standard Deviation 23.32
|
3.25 score on a scale
Standard Deviation 10.01
|
3.81 score on a scale
Standard Deviation 15.7
|
5.05 score on a scale
Standard Deviation 18.86
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Constipation
|
0 score on a scale
Standard Deviation 20.33
|
0 score on a scale
Standard Deviation 13.61
|
0.68 score on a scale
Standard Deviation 14.42
|
1.42 score on a scale
Standard Deviation 16.96
|
5.43 score on a scale
Standard Deviation 26.16
|
1.39 score on a scale
Standard Deviation 21.7
|
-0.79 score on a scale
Standard Deviation 11.61
|
0.98 score on a scale
Standard Deviation 12.94
|
0 score on a scale
Standard Deviation 20.74
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Diarrhea
|
0.76 score on a scale
Standard Deviation 11.34
|
0 score on a scale
Standard Deviation 15.21
|
0.68 score on a scale
Standard Deviation 15.94
|
-0.71 score on a scale
Standard Deviation 8.48
|
0 score on a scale
Standard Deviation 12.75
|
1.39 score on a scale
Standard Deviation 13.68
|
2.38 score on a scale
Standard Deviation 15.43
|
2.02 score on a scale
Standard Deviation 16.54
|
1.04 score on a scale
Standard Deviation 15.8
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Emotional Functioning
|
1.07 score on a scale
Standard Deviation 14.82
|
0.34 score on a scale
Standard Deviation 15.31
|
1.93 score on a scale
Standard Deviation 15.3
|
2.3 score on a scale
Standard Deviation 15.22
|
4.52 score on a scale
Standard Deviation 10.2
|
1.56 score on a scale
Standard Deviation 16.09
|
0.79 score on a scale
Standard Deviation 15.49
|
3.43 score on a scale
Standard Deviation 11.07
|
4.25 score on a scale
Standard Deviation 10.27
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Fatigue
|
5.68 score on a scale
Standard Deviation 19.23
|
7.26 score on a scale
Standard Deviation 13.38
|
3.51 score on a scale
Standard Deviation 15.16
|
3.78 score on a scale
Standard Deviation 15.59
|
1.64 score on a scale
Standard Deviation 14.99
|
1.62 score on a scale
Standard Deviation 16.04
|
0.4 score on a scale
Standard Deviation 14.12
|
2.86 score on a scale
Standard Deviation 16.47
|
5.05 score on a scale
Standard Deviation 16.45
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Financial Difficulties
|
0.81 score on a scale
Standard Deviation 26.34
|
-0.72 score on a scale
Standard Deviation 21.65
|
-2.9 score on a scale
Standard Deviation 19.66
|
-6.06 score on a scale
Standard Deviation 21.89
|
-4.17 score on a scale
Standard Deviation 18.78
|
-1.48 score on a scale
Standard Deviation 22.42
|
-6.84 score on a scale
Standard Deviation 19.01
|
-5.21 score on a scale
Standard Deviation 17.16
|
-4.6 score on a scale
Standard Deviation 14.7
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Insomnia
|
-2.33 score on a scale
Standard Deviation 23.45
|
3.47 score on a scale
Standard Deviation 25.02
|
2.72 score on a scale
Standard Deviation 33.22
|
2.17 score on a scale
Standard Deviation 28.46
|
-1.52 score on a scale
Standard Deviation 28.71
|
5.67 score on a scale
Standard Deviation 28.93
|
3.25 score on a scale
Standard Deviation 29.63
|
5.71 score on a scale
Standard Deviation 24.9
|
3.03 score on a scale
Standard Deviation 24.1
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Nausea and Vomiting
|
2.71 score on a scale
Standard Deviation 10.87
|
1.7 score on a scale
Standard Deviation 7.01
|
1.36 score on a scale
Standard Deviation 6.66
|
2.48 score on a scale
Standard Deviation 10.41
|
3.79 score on a scale
Standard Deviation 16.42
|
1.74 score on a scale
Standard Deviation 7.87
|
0 score on a scale
Standard Deviation 3.73
|
1.43 score on a scale
Standard Deviation 7.42
|
0 score on a scale
Standard Deviation 4.17
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Physical Functioning
|
0.67 score on a scale
Standard Deviation 6.53
|
-0.11 score on a scale
Standard Deviation 11.19
|
-1.58 score on a scale
Standard Deviation 14.25
|
-2.6 score on a scale
Standard Deviation 11.59
|
-0.66 score on a scale
Standard Deviation 9.84
|
-1.99 score on a scale
Standard Deviation 12.58
|
-1.63 score on a scale
Standard Deviation 11.41
|
-1.21 score on a scale
Standard Deviation 10.62
|
-2.79 score on a scale
Standard Deviation 8.18
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Role Functioning
|
0 score on a scale
Standard Deviation 23.85
|
0.68 score on a scale
Standard Deviation 14.42
|
0.34 score on a scale
Standard Deviation 12.02
|
-0.35 score on a scale
Standard Deviation 16.11
|
1.14 score on a scale
Standard Deviation 14.56
|
1.74 score on a scale
Standard Deviation 12.51
|
-0.4 score on a scale
Standard Deviation 16.66
|
0 score on a scale
Standard Deviation 23.22
|
-5.56 score on a scale
Standard Deviation 20.27
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Social Functioning
|
-1.14 score on a scale
Standard Deviation 19.49
|
2.38 score on a scale
Standard Deviation 11.28
|
2.38 score on a scale
Standard Deviation 12.27
|
2.48 score on a scale
Standard Deviation 14.74
|
4.26 score on a scale
Standard Deviation 13.16
|
1.74 score on a scale
Standard Deviation 15.47
|
1.98 score on a scale
Standard Deviation 14.82
|
3.43 score on a scale
Standard Deviation 14.67
|
4.69 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5Population: If participants did not complete the questionnaire or did not complete a question then they are not included in the number analyzed.
The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. For the four symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms) a high score correlates to high levels of symptoms or problems and a worse outcome. For the four functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) a high score correlates to a high/healthy level of functioning or a better outcome
Outcome measures
| Measure |
Treatment (HG-PBI)
n=44 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=48 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
n=46 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
n=43 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
n=41 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
n=34 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
n=32 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Arm Symptoms
|
-2.02 score on a scale
Standard Deviation 11.05
|
-0.69 score on a scale
Standard Deviation 12
|
-0.47 score on a scale
Standard Deviation 15.18
|
-1.45 score on a scale
Standard Deviation 11.14
|
-3.23 score on a scale
Standard Deviation 14.1
|
-1.89 score on a scale
Standard Deviation 12.33
|
-3.52 score on a scale
Standard Deviation 15.8
|
-4.9 score on a scale
Standard Deviation 18.59
|
-2.08 score on a scale
Standard Deviation 11.79
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Body Image
|
2.31 score on a scale
Standard Deviation 10.32
|
1.6 score on a scale
Standard Deviation 8.97
|
0 score on a scale
Standard Deviation 7.66
|
-0.37 score on a scale
Standard Deviation 10.65
|
1.23 score on a scale
Standard Deviation 10.49
|
0.66 score on a scale
Standard Deviation 9.45
|
-0.9 score on a scale
Standard Deviation 13.17
|
-0.98 score on a scale
Standard Deviation 14.76
|
-1.61 score on a scale
Standard Deviation 12.98
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Breast Symptoms
|
-1.83 score on a scale
Standard Deviation 11.54
|
-3.3 score on a scale
Standard Deviation 15.54
|
-6.86 score on a scale
Standard Deviation 14.74
|
-8.76 score on a scale
Standard Deviation 10.44
|
-10.08 score on a scale
Standard Deviation 11.72
|
-9.63 score on a scale
Standard Deviation 13.57
|
-11.04 score on a scale
Standard Deviation 11.94
|
-8.25 score on a scale
Standard Deviation 11.16
|
-8.94 score on a scale
Standard Deviation 10.65
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Future Perspective
|
-3.97 score on a scale
Standard Deviation 18.34
|
-4.96 score on a scale
Standard Deviation 25.04
|
-2.17 score on a scale
Standard Deviation 23.73
|
-7.41 score on a scale
Standard Deviation 24.5
|
-6.2 score on a scale
Standard Deviation 31.92
|
-4.35 score on a scale
Standard Deviation 23.94
|
-7.5 score on a scale
Standard Deviation 26.67
|
-11.76 score on a scale
Standard Deviation 29.45
|
-10.75 score on a scale
Standard Deviation 29.04
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Sexual Enjoyment
|
2.38 score on a scale
Standard Deviation 15.82
|
4.76 score on a scale
Standard Deviation 25.68
|
-2.78 score on a scale
Standard Deviation 26.43
|
0 score on a scale
Standard Deviation 21.82
|
5.56 score on a scale
Standard Deviation 19.25
|
2.56 score on a scale
Standard Deviation 21.35
|
9.09 score on a scale
Standard Deviation 30.15
|
-4.76 score on a scale
Standard Deviation 12.6
|
-5.56 score on a scale
Standard Deviation 13.61
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Sexual Functioning
|
-4.88 score on a scale
Standard Deviation 17.18
|
-4.35 score on a scale
Standard Deviation 17.72
|
-3.88 score on a scale
Standard Deviation 14.01
|
-5.16 score on a scale
Standard Deviation 15.39
|
-7.5 score on a scale
Standard Deviation 14.1
|
-0.39 score on a scale
Standard Deviation 19.41
|
-5.41 score on a scale
Standard Deviation 19.66
|
-4.02 score on a scale
Standard Deviation 23.42
|
-1.19 score on a scale
Standard Deviation 21.24
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Systemic Therapy Side Effects
|
3.7 score on a scale
Standard Deviation 10.3
|
7.75 score on a scale
Standard Deviation 10.76
|
8.1 score on a scale
Standard Deviation 11.46
|
5.13 score on a scale
Standard Deviation 12.22
|
3.75 score on a scale
Standard Deviation 8.71
|
4.67 score on a scale
Standard Deviation 10.26
|
2.72 score on a scale
Standard Deviation 7.71
|
2.5 score on a scale
Standard Deviation 7.02
|
3.14 score on a scale
Standard Deviation 10.38
|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Upset by Hair Loss
|
33.33 score on a scale
Standard Deviation NA
There was only one participant evaluable so SD is not available.
|
16.67 score on a scale
Standard Deviation 33.33
|
-26.67 score on a scale
Standard Deviation 43.46
|
-20 score on a scale
Standard Deviation 29.81
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 27.22
|
-44.44 score on a scale
Standard Deviation 38.49
|
0 score on a scale
Standard Deviation 0
|
-50 score on a scale
Standard Deviation 23.57
|
SECONDARY outcome
Timeframe: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5Population: If participants did not complete the questionnaire then they are not included in the number analyzed.
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor (0) and "severe pain" at (10) with the patient's mark providing a range of scores from 0-100 millimeters. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=41 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=49 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
n=44 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
n=42 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
n=49 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
n=39 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
n=35 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
n=31 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain
|
-0.34 mm
Standard Deviation 0.94
|
-0.14 mm
Standard Deviation 1.29
|
-0.43 mm
Standard Deviation 1.44
|
-0.59 mm
Standard Deviation 1.23
|
-0.67 mm
Standard Deviation 1.49
|
-0.63 mm
Standard Deviation 1.51
|
-0.62 mm
Standard Deviation 1.14
|
-0.6 mm
Standard Deviation 1.29
|
-0.74 mm
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5Population: If participants missed the BRA then they are not included in the number analyzed.
This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=49 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
n=46 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
n=42 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
n=37 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
n=33 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
n=27 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA)
|
-0.14 cm
Standard Deviation 1.08
|
0.22 cm
Standard Deviation 3.41
|
-0.15 cm
Standard Deviation 2.89
|
-0.5 cm
Standard Deviation 1.08
|
0.21 cm
Standard Deviation 3.09
|
0.34 cm
Standard Deviation 4.08
|
0.91 cm
Standard Deviation 4.85
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5Population: If participants did not have the percentage Breast Retraction Assessment then they are not included in the analysis.
This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. This is calculated from dividing the BRA score by the reference length from sternal notch to contralateral nipple and then multiplying that value by 100 to get a percentage.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=48 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
n=44 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
n=43 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
n=35 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
n=31 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
n=28 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA)
|
-1.05 percentage breast retraction
Standard Deviation 5.14
|
-0.67 percentage breast retraction
Standard Deviation 10.37
|
-1.81 percentage breast retraction
Standard Deviation 9.71
|
-2.93 percentage breast retraction
Standard Deviation 5.24
|
-1.76 percentage breast retraction
Standard Deviation 9.2
|
-1.56 percentage breast retraction
Standard Deviation 11.29
|
-0.03 percentage breast retraction
Standard Deviation 14.29
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5Population: If physicians did not complete the evaluation with the participant then they are not included in the number analyzed.
Using this scale, cosmesis is qualitatively evaluated by the treating radiation oncologist by comparing the treated breast with the contralateral breast using the Aronson Modified Scale. The global cosmetic result, appearance of the surgical scar, breast size, breast shape, skin color, location of the areola and nipple, and shape of the areola and nipple were scored on a 4-point scale. In this case 1 is 'excellent' with 4 being 'poor.'
Outcome measures
| Measure |
Treatment (HG-PBI)
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=47 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
n=44 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
n=38 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
n=42 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
n=37 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
n=33 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
n=29 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale.
|
-0.04 score on a scale
Standard Deviation 0.36
|
-0.09 score on a scale
Standard Deviation 0.28
|
0.02 score on a scale
Standard Deviation 0.4
|
0.03 score on a scale
Standard Deviation 0.37
|
0 score on a scale
Standard Deviation 0.31
|
0.05 score on a scale
Standard Deviation 0.4
|
0.09 score on a scale
Standard Deviation 0.58
|
0.21 score on a scale
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsAcute complications are defined as complications that occurred from start of treatment until day 90. Late complications are defined as complications that occurred from Day 91 until completion of 5 year follow-up.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Complications Using CTCAE v. 4.0
Alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Alopecia
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Anemia
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Arthralgia
|
6 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Ataxia
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Atrial Fibrillation
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Back Pain
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Breast Atrophy
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Breast Pain
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Bronchial Infection
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Congestive heart failure
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Chest pain - Cardiac
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Chest Wall Pain
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Chills
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Chronic kidney disease
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Constipation
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Cough
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Depression
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Diarrhea
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Dizziness
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Dry Mouth
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Dry Skin
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Dyspnea
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Edema Limbs
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Ejection fraction decreased
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Epistaxis
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Fall
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Fatigue
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Fibrosis deep connective tissue
|
1 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Flank Pain
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Gastroesophageal reflux disease
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Poor dentition
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Headache
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Heart Failure
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Hematoma
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Hot Flashes
|
13 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Hyperhidrosis
|
10 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Hyperkalemia
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Hypertension
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Candida infection
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
COVID-19 infection
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Insomnia
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Irritability
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Joint infection
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Memory Impairment
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Shoulder pain
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Myocardial Infarction
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Nausea
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Neck Pain
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Neutrophil Count Decreased
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Nipple deformity
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Pain in extremity
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Pain
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Pericardial Effusion
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Platelet Count decrease
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Seroma
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Skin Atrophy
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Skin Hyperpigmentation
|
15 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Skin Induration
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Skin Infection
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Superficial soft tissue fibrosis
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Telangiectasia
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Thrombotic event
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Tremor
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Upper respiratory Infection
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Urticaria
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Vaginal Pain
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Vertigo
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Vomiting
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
White blood cell decrease
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Shingles
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Scar retraction
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Complications Using CTCAE v. 4.0
Trigger finger
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsAcute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Outcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0
Late - fibrosis deep connective tissue
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0
Late - neutrophil count decreased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0
Late - white blood cell decreased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 5 yearsOutcome measures
| Measure |
Treatment (HG-PBI)
n=50 Participants
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 8 Weeks
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 6 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 12 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 18 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 24 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - 36 Months
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 4
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Year 5
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Undergoing Mastectomy on the Treated Side
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (HG-PBI) - Acute
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Treatment (HG-PBI) - Late
Serious events: 0 serious events
Other events: 48 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (HG-PBI) - Acute
n=50 participants at risk
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
Treatment (HG-PBI) - Late
n=50 participants at risk
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
4.0%
2/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
4.0%
2/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Poor dentition
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
General disorders
Chills
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
General disorders
Edema limbs
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
General disorders
Fatigue
|
4.0%
2/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
8.0%
4/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
General disorders
Pain
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
General disorders
Pain in extremity
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
Candida infection
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
Joint infection
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
Shingles
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
Skin infection
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
4.0%
2/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Scar retraction
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Seroma
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Investigations
Platelet count decreased
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Investigations
White blood cell decreased
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
60.0%
30/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
8.0%
4/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
48.0%
24/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
4.0%
2/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
14.0%
7/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Nervous system disorders
Tremor
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Reproductive system and breast disorders
Breast atrophy
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Reproductive system and breast disorders
Breast pain
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
14.0%
7/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Reproductive system and breast disorders
Nipple deformity
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
8.0%
4/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
6.0%
3/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
10/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
44.0%
22/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
10.0%
5/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
30.0%
15/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
32.0%
16/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
8.0%
4/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Vascular disorders
Hematoma
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Vascular disorders
Hot flashes
|
26.0%
13/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
68.0%
34/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
|
Vascular disorders
Thrombotic event
|
0.00%
0/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
2.0%
1/50 • Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
|
Additional Information
Imran Zoberi, M.D.
Washington University School of Medicine
Phone: 314-362-8610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place