Trial Outcomes & Findings for Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes (NCT NCT02700386)
NCT ID: NCT02700386
Last Updated: 2025-10-27
Results Overview
The composite endpoint is "yes" for a given patient if that patient experienced at least one of six component adverse events: lymphedema, shoulder ROM impairment, cardiac ischemia, symptomatic rib fracture, brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL'), or Grade 2 pneumonitis (requires steroids). AEs were assessed by CTCAE version 4.03.
ACTIVE_NOT_RECRUITING
PHASE2
108 participants
12 months and 36 months
2025-10-27
Participant Flow
Participant milestones
| Measure |
Adjuvant Hypofractionated Radiation
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes
Baseline characteristics by cohort
| Measure |
Adjuvant Hypofractionated Radiation
n=108 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients are included in analysis for this outcome measure if they have an event recorded for at least one of the six components of the composite endpoint, or if they had non-missing data for all six components.
The composite endpoint is "yes" for a given patient if that patient experienced at least one of six component adverse events: lymphedema, shoulder ROM impairment, cardiac ischemia, symptomatic rib fracture, brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL'), or Grade 2 pneumonitis (requires steroids). AEs were assessed by CTCAE version 4.03.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=90 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With at Least One Treatment-related Adverse Event of Interest
12 months
|
15 Participants
|
|
Number of Participants With at Least One Treatment-related Adverse Event of Interest
36 months
|
20 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients who were missing a follow-up assessment at the given dates were excluded.
An increase in interlimb arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint, will be judged to be clinically significant lymphedema. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be assessed at 12 months and at 36 months.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=90 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference
12 months
|
11 Participants
|
|
Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference
36 months
|
15 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients who were missing a follow-up assessment at the given times for this endpoint were excluded.
Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=92 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT
36 months
|
0 Participants
|
|
Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT
12 months
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients who were missing a follow-up assessment for this outcome measure at the given time points were excluded.
Ischemic heart disease will be measured by the new development of angina with corresponding EKG changes, or myocardial infraction.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=92 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG
12 months
|
0 Participants
|
|
Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG
36 months
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients were excluded if they were missing data for this event.
Shoulder stiffness severity is assessed using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire breast cancer module (EORTC QLQ-BR23). It is assessed based on patient response to the questionnaire item, "During the past week, was it difficult to raise your arm or to move it sideways?", which is scored from 1 to 4 with 1 being "not at all" and 4 being "very much". Shoulder stiffness is identified in a patient when their response to that question is 3 or 4 AND if their response increased numerically from their response on day 1.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=92 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23
12 months
|
5 Participants
|
|
Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23
36 months
|
6 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients who were missing an assessment for this endpoint were excluded.
Number of patients who experience pneumonitis as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=90 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Grade 2 or Higher Pneumonitis
12 months
|
0 Participants
|
|
Number of Participants With Grade 2 or Higher Pneumonitis
36 months
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months and 36 monthsPopulation: Patients who were missing an assessment for this endpoint were excluded.
Number of patients who experience brachial plexopathy as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=92 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Grade 2 or Higher Brachial Plexopathy
12 months
|
0 Participants
|
|
Number of Participants With Grade 2 or Higher Brachial Plexopathy
36 months
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: 2 subjects of 108 total were excluded due to having no follow-up data.
Recurrent disease presentation within axillary lymph node levels I, II, or III. The supraclavicular region is not included in this endpoint.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=106 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Disease Recurrence
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months and 36 monthsPopulation: 2 participants who did not have a follow-up visit to assess metastasis status were excluded.
Measured by the time from date of enrollment to earlier of clinical detection of metastatic disease beyond the breast/chestwall and regional lymph nodes or death.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=106 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Metastasis-free Survival
12 months
|
106 Participants
|
|
Number of Participants With Metastasis-free Survival
36 months
|
103 Participants
|
SECONDARY outcome
Timeframe: 12 months and 36 monthsPopulation: 2 participants did not have a follow-up visit where local or regional disease recurrence was assessed and were excluded from this outcome measure.
Measured by the time from date of enrollment to earlier of clinical detection of any ipsilateral recurrent disease to the breast/chestwall or regional lymph nodes (levels I, II, III, supraclavicular, and internal mammary lymph nodes) or death.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=106 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With Local-regional Failure Free Survival
36 months
|
104 Participants
|
|
Number of Participants With Local-regional Failure Free Survival
12 months
|
106 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 12 monthsPopulation: This is the number of patients who completed the EORTC QLQ-C30 at both baseline and 1 year post-intervention.
Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire \[EORTC QLQ-C30 V1\]. Summary scores and missing data handling were performed according to the EORTC QLQ-C30. The minimum score is 0, and the maximum score is 100. A higher score is a better outcome. A change in score is defined as a score increase of at least 10 points at the 12 month mark compared to baseline.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=86 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-C30
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-interventionPopulation: This is the number of patients who completed the EORTC QLQ-BR23 at both baseline and 1 year post-intervention.
Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire breast cancer module \[EORTC QLQ-BR23 V1\]. Summary scores and missing data handling were performed according to the EORTC QLQ-BR23. The minimum score is 0, and the maximum score is 100. A higher score is a better outcome. A change in score is defined as a score increase of at least 10 points from baseline.
Outcome measures
| Measure |
Adjuvant Hypofractionated Radiation
n=79 Participants
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-BR23
|
17 Participants
|
Adverse Events
Adjuvant Hypofractionated Radiation
Serious adverse events
| Measure |
Adjuvant Hypofractionated Radiation
n=108 participants at risk
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
Infections and infestations
Skin infection
|
0.93%
1/108 • Number of events 2 • 5 years
|
|
Infections and infestations
Breast infection
|
0.93%
1/108 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain mets/progression
|
0.93%
1/108 • Number of events 2 • 5 years
|
|
General disorders
Death NOS
|
1.9%
2/108 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.93%
1/108 • Number of events 1 • 5 years
|
|
Vascular disorders
Hematoma
|
0.93%
1/108 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.93%
1/108 • Number of events 1 • 5 years
|
|
Infections and infestations
Sepsis
|
0.93%
1/108 • Number of events 1 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
1.9%
2/108 • Number of events 2 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/108 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.93%
1/108 • Number of events 1 • 5 years
|
|
General disorders
Disease progression
|
0.93%
1/108 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Adjuvant Hypofractionated Radiation
n=108 participants at risk
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Adjuvant Hypofractionated Radiation: Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
|
|---|---|
|
General disorders
Fatigue
|
64.8%
70/108 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
41.7%
45/108 • 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
31.5%
34/108 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
31.5%
34/108 • 5 years
|
|
Vascular disorders
Hot flashes
|
27.8%
30/108 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
51.9%
56/108 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.4%
22/108 • 5 years
|
|
Vascular disorders
Lymphedema
|
17.6%
19/108 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
15.7%
17/108 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
13.9%
15/108 • 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
20.4%
22/108 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
13.0%
14/108 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
12/108 • 5 years
|
|
Psychiatric disorders
Anxiety
|
10.2%
11/108 • 5 years
|
|
Psychiatric disorders
Insomnia
|
9.3%
10/108 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.3%
10/108 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
9/108 • 5 years
|
|
Nervous system disorders
Neuropathy
|
8.3%
9/108 • 5 years
|
|
General disorders
Breast tenderness
|
7.4%
8/108 • 5 years
|
|
Nervous system disorders
Headache
|
12.0%
13/108 • 5 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
7.4%
8/108 • 5 years
|
|
Skin and subcutaneous tissue disorders
Desquamation
|
6.5%
7/108 • 5 years
|
|
Cardiac disorders
Chest tightness
|
5.6%
6/108 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
6/108 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
5.6%
6/108 • 5 years
|
Additional Information
Christine Fisher, MD, MPH
University of Colorado, Denver
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place