Trial Outcomes & Findings for Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer (NCT NCT00325598)
NCT ID: NCT00325598
Last Updated: 2018-06-06
Results Overview
-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Within 1 year of protocol registration
Results posted on
2018-06-06
Participant Flow
The study opened to participant enrollment on 02/14/2006 and closed to participant enrollment on 04/11/2012.
Participant milestones
| Measure |
Cohort 1 (36 Gy)
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 (36 Gy)
n=50 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
59 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 1 year of protocol registration-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=50 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Within 1 year of protocol registration-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=50 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity
|
0 percentage of participants
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.
* Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme * Grade 0 = none * Grade 1 = slight atrophy; pigmentation change; some hair loss * Grade 2 = patch atrophy; moderate telangiectasia; total hair loss * Grade 3 = marked atrophy; gross telangiectasia * Grade 4 = ulceration * Worst cutaneous toxicity grade is noted
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=48 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Incidence and Severity of Cutaneous Toxicity
Grade 0
|
4 Participants
|
0 Participants
|
|
Incidence and Severity of Cutaneous Toxicity
Grade 1
|
30 Participants
|
22 Participants
|
|
Incidence and Severity of Cutaneous Toxicity
Grade 2
|
12 Participants
|
19 Participants
|
|
Incidence and Severity of Cutaneous Toxicity
Grade 3
|
2 Participants
|
9 Participants
|
|
Incidence and Severity of Cutaneous Toxicity
Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=48 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Incidence of Breast Fibrosis
|
36 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.
-Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat.
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=48 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Incidence of Fat Necrosis
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 4 patients in Cohort 1 were not evaluable for this outcome measure because 2 patients did not have the cosmetic outcome performed, 1 patient withdrew consent, and 1 patient was lost to follow-up.
* Excellent: little or no observable change * Good: minimal but identifiable changes * Fair: significant results of radiotherapy noted * Poor: severe normal tissue sequelae
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=46 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Cosmetic Outcome
Excellent
|
6 Participants
|
11 Participants
|
|
Cosmetic Outcome
Good
|
30 Participants
|
32 Participants
|
|
Cosmetic Outcome
Fair
|
9 Participants
|
3 Participants
|
|
Cosmetic Outcome
Poor
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.
-Local control rate for this study is the number of participants who remained free of disease in their breast.
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=48 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Local Control Rate
|
48 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.
-Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=48 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Regional Control Rate
|
48 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.
-Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes.
Outcome measures
| Measure |
Cohort 1 (36 Gy)
n=48 Participants
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
|
Cohort 2 (40 Gy)
n=50 Participants
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
|
|---|---|---|
|
Distant Control Rate
|
48 Participants
|
50 Participants
|
Adverse Events
Cohort 1 (36 Gy) Acute Toxicities
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort 1 (36 Gy) Late Toxicities
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 2 (40 Gy) Acute Toxicities
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 2 (40 Gy) Late Toxicities
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (36 Gy) Acute Toxicities
n=50 participants at risk
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 1 through Day 90
|
Cohort 1 (36 Gy) Late Toxicities
n=50 participants at risk
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 1 through Day 90
|
Cohort 2 (40 Gy) Acute Toxicities
n=50 participants at risk
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 91 through end of follow-up
|
Cohort 2 (40 Gy) Late Toxicities
n=50 participants at risk
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 91 through end of follow-up
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast pain
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Infections and infestations
Infection (mastitis)
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Breast edema
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Fever
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Rigors/chills
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Chest pain
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Costochondritis
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
Other adverse events
| Measure |
Cohort 1 (36 Gy) Acute Toxicities
n=50 participants at risk
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 1 through Day 90
|
Cohort 1 (36 Gy) Late Toxicities
n=50 participants at risk
36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 1 through Day 90
|
Cohort 2 (40 Gy) Acute Toxicities
n=50 participants at risk
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 91 through end of follow-up
|
Cohort 2 (40 Gy) Late Toxicities
n=50 participants at risk
40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 91 through end of follow-up
|
|---|---|---|---|---|
|
Investigations
ALT
|
0.00%
0/50
|
4.0%
2/50
|
2.0%
1/50
|
6.0%
3/50
|
|
Investigations
AST
|
0.00%
0/50
|
6.0%
3/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Psychiatric disorders
Agitation
|
0.00%
0/50
|
0.00%
0/50
|
8.0%
4/50
|
4.0%
2/50
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
4.0%
2/50
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50
|
2.0%
1/50
|
4.0%
2/50
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Back/sacral pain
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Eye disorders
Blurred vision
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Breast assymmetry
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Breast function/lactation
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Reproductive system and breast disorders
Breast pain
|
4.0%
2/50
|
28.0%
14/50
|
50.0%
25/50
|
50.0%
25/50
|
|
Reproductive system and breast disorders
Breast volume/hypoplasia
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3/4 thrombocytopenia)
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Cardiac disorders
Cardiac conduction abnormality NOS
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
10.0%
5/50
|
|
Musculoskeletal and connective tissue disorders
Chest/shoulder pain
|
0.00%
0/50
|
0.00%
0/50
|
6.0%
3/50
|
0.00%
0/50
|
|
Investigations
Cholesterol, serum-high
|
0.00%
0/50
|
6.0%
3/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Investigations
Creatinine
|
0.00%
0/50
|
6.0%
3/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Psychiatric disorders
Depression
|
0.00%
0/50
|
6.0%
3/50
|
4.0%
2/50
|
4.0%
2/50
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50
|
8.0%
4/50
|
4.0%
2/50
|
4.0%
2/50
|
|
General disorders
Edema - Nipple/Areolar
|
2.0%
1/50
|
4.0%
2/50
|
2.0%
1/50
|
2.0%
1/50
|
|
General disorders
Edema - breast
|
4.0%
2/50
|
10.0%
5/50
|
20.0%
10/50
|
20.0%
10/50
|
|
General disorders
Edema: arm
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Edema: extremity
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
General disorders
Edema: limb
|
0.00%
0/50
|
2.0%
1/50
|
4.0%
2/50
|
10.0%
5/50
|
|
General disorders
Edema: trunk
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.0%
3/50
|
6.0%
3/50
|
30.0%
15/50
|
4.0%
2/50
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Fatigue
|
4.0%
2/50
|
12.0%
6/50
|
24.0%
12/50
|
10.0%
5/50
|
|
Musculoskeletal and connective tissue disorders
Fibrosis - cosmesis
|
0.00%
0/50
|
4.0%
2/50
|
22.0%
11/50
|
16.0%
8/50
|
|
Skin and subcutaneous tissue disorders
Fibrosis - deep connective tissue
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Fibrosis/induration
|
6.0%
3/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
6.0%
3/50
|
|
Nervous system disorders
Headache
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/50
|
4.0%
2/50
|
6.0%
3/50
|
4.0%
2/50
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/50
|
10.0%
5/50
|
16.0%
8/50
|
18.0%
9/50
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/50
|
6.0%
3/50
|
4.0%
2/50
|
2.0%
1/50
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/50
|
6.0%
3/50
|
0.00%
0/50
|
8.0%
4/50
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.0%
3/50
|
6.0%
3/50
|
52.0%
26/50
|
34.0%
17/50
|
|
Vascular disorders
Hypertension
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
8.0%
4/50
|
|
Investigations
Hypertriglyceridemia
|
0.00%
0/50
|
4.0%
2/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Investigations
Hypokalemia
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
6.0%
3/50
|
|
Investigations
Hyponatremia
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Vascular disorders
Hypotension
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Infections and infestations
Infection with unknown ANC - bronchus
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Infections and infestations
Infection with unknown ANC - ungual
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50
|
0.00%
0/50
|
8.0%
4/50
|
6.0%
3/50
|
|
Musculoskeletal and connective tissue disorders
Joint function
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/50
|
10.0%
5/50
|
6.0%
3/50
|
18.0%
9/50
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Investigations
Leukocytes
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
4.0%
2/50
|
|
Reproductive system and breast disorders
Libido
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Investigations
Lymphopenia
|
0.00%
0/50
|
2.0%
1/50
|
10.0%
5/50
|
12.0%
6/50
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
6.0%
3/50
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - stiffness
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
4.0%
2/50
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Neuropathy: balance
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Nervous system disorders
Neuropathy: cranial - CN VIII hearing and balance
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Nervous system disorders
Neuropathy: cranial - CN VIII sensory-taste
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Orgasmic dysfunction
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Investigations
Platelets
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.0%
1/50
|
2.0%
1/50
|
4.0%
2/50
|
4.0%
2/50
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation
|
0.00%
0/50
|
2.0%
1/50
|
42.0%
21/50
|
6.0%
3/50
|
|
Musculoskeletal and connective tissue disorders
Rib tenderness
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
|
General disorders
Rigors/chills
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Nervous system disorders
Sensory neuropathy
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.0%
1/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/50
|
6.0%
3/50
|
8.0%
4/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/50
|
6.0%
3/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
2.0%
1/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Nervous system disorders
Tremor
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Infections and infestations
Unknown skin - Skin (cellulitis)
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/50
|
2.0%
1/50
|
2.0%
1/50
|
2.0%
1/50
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/50
|
4.0%
2/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
|
Cardiac disorders
Valvular heart disease
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
0.00%
0/50
|
2.0%
1/50
|
0.00%
0/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
|
Eye disorders
Watery eye
|
0.00%
0/50
|
0.00%
0/50
|
0.00%
0/50
|
2.0%
1/50
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
0.00%
0/50
|
0.00%
0/50
|
4.0%
2/50
|
2.0%
1/50
|
Additional Information
Imran Zoberi, M.D.
Washington University School of Medicine
Phone: 314-362-8525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place