Trial Outcomes & Findings for Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg (NCT NCT00589121)
NCT ID: NCT00589121
Last Updated: 2019-06-12
Results Overview
The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
2 years after start of treatment (+/- 3 months)
Results posted on
2019-06-12
Participant Flow
Participant milestones
| Measure |
Cohort A - Chemotherapy
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
86
|
|
Overall Study
COMPLETED
|
10
|
79
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
Cohort A - Chemotherapy
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
6
|
|
Overall Study
No protocol treatment received
|
0
|
1
|
Baseline Characteristics
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Baseline characteristics by cohort
| Measure |
Cohort A - Chemotherapy
n=10 Participants
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=99 Participants
|
61 years
n=107 Participants
|
61 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 years after start of treatment (+/- 3 months)Population: All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)
The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=57 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria
|
10.5 percentage of participants
Interval 2.6 to 18.5
|
—
|
SECONDARY outcome
Timeframe: From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Local Failure Rate at Two Years
|
11.4 percentage of participants
Interval 5.6 to 19.6
|
—
|
SECONDARY outcome
Timeframe: From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Regional Failure Rate at Two Years
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Distant Failure Rate at Two Years
|
37.3 percentage of participants
Interval 26.6 to 48.0
|
—
|
SECONDARY outcome
Timeframe: From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Distant Disease-free Survival Rate at Two Years
|
61.4 percentage of participants
Interval 50.6 to 72.2
|
—
|
SECONDARY outcome
Timeframe: From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Disease-free Survival Rate at Two Years
|
58.1 percentage of participants
Interval 47.1 to 69.0
|
—
|
SECONDARY outcome
Timeframe: From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Overall Survival Rate at Two Years
|
80.6 percentage of participants
Interval 71.8 to 89.4
|
—
|
SECONDARY outcome
Timeframe: From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Second Primary Tumor Rate at Two Years
|
5.1 percentage of participants
Interval 1.7 to 11.7
|
—
|
SECONDARY outcome
Timeframe: 2 years after start of treatment (+/- 3 months)Population: All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=57 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0
|
8.8 percentage of participants
Interval 1.4 to 16.1
|
—
|
SECONDARY outcome
Timeframe: From date of surgery to 4 months post-surgeryPopulation: All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.)
Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=71 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Percentage of Patients With Wound Complications
|
36.6 percentage of participants
Interval 25.4 to 47.8
|
—
|
SECONDARY outcome
Timeframe: From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.)
Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=10 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Pattern of First Failure
Regional
|
0 participants
|
1 participants
|
|
Pattern of First Failure
Local
|
1 participants
|
8 participants
|
|
Pattern of First Failure
Distant
|
1 participants
|
29 participants
|
|
Pattern of First Failure
Dead without disease progression
|
0 participants
|
2 participants
|
|
Pattern of First Failure
Alive without disease progression
|
8 participants
|
39 participants
|
SECONDARY outcome
Timeframe: From start of treatment to 2 years.Population: All eligible patients on Cohort B who had a 2-year MSTS assessment. (See limitations and caveats, Cohort A is not included.)
The Musculoskeletal Tumor Rating Scale (MSTS) is a measure of physical function across 7 items, completed by the physician (preferably by the Orthopedic Surgeon or Surgical Oncologist) or the physician's designated staff. The 7 items are: pain, range of motion, strength, joint stability, joint deformity, emotional, acceptance, and overall function. Each item is scored from 0-5 (worst possible to best possible condition). The item scores are summed to get the total score which ranges from 0-35. Late radiation morbidity is defined as ≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=18 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
n=2 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years
|
31.3 units on a scale
Standard Deviation 4.5
|
25.0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.Population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Cohort B - No Chemotherapy
n=79 Participants
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events
|
38.0 percentage of patients
Interval 27.3 to 49.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years after start of treatment (+/- 3 months)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years after start of treatment (+/- 3 months)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years after start of treatment (+/- 3 months)Outcome measures
Outcome data not reported
Adverse Events
Cohort A - Chemotherapy
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort B - No Chemotherapy
Serious events: 13 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A - Chemotherapy
n=10 participants at risk
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
n=79 participants at risk
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Fatigue
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Infection [other]
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Skin infection [with normal or Grade 1-2 ANC]
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Wound infection [with normal or Grade 1-2 ANC]
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Arterial injury - Extremity-lower
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Late RT Toxicity: subcutaneous tissue: NOS
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Laboratory test abnormal
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Leukopenia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Lymphopenia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Late RT Toxicity: joint: NOS
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Neuralgia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Thrombosis
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Vascular disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
Other adverse events
| Measure |
Cohort A - Chemotherapy
n=10 participants at risk
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
Cohort B - No Chemotherapy
n=79 participants at risk
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
30.0%
3/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
24.1%
19/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Blood and lymphatic system disorders
Hemolysis
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Cardiac disorders
Left ventricular failure
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Cardiac disorders
Premature ventricular contractions
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Eye disorders
Diplopia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
16.5%
13/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Chills
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Edema limbs
|
60.0%
6/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
74.7%
59/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Fatigue
|
30.0%
3/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
34.2%
27/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Fever
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Gait abnormal
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
7.6%
6/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
General symptom
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Ill-defined disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Localized edema [trunk/genital]
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Pain [NOS]
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Pain [other]
|
30.0%
3/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
12.7%
10/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
General disorders
Stern's Scale Toxicity: edema: NOS
|
60.0%
6/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
74.7%
59/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Gastric infection [with unknown ANC]
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Infection [other]
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Skin infection [with normal or Grade 1-2 ANC]
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Wound infection [with normal or Grade 1-2 ANC]
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
12.7%
10/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Infections and infestations
Wound infection [with unknown ANC]
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
27.8%
22/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Late RT Toxicity: subcutaneous tissue: NOS
|
50.0%
5/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
31.6%
25/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
12.7%
10/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
12.7%
10/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Hyperbilirubinemia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Laboratory test abnormal
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Leukopenia
|
30.0%
3/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Lymphopenia
|
40.0%
4/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
8.9%
7/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Platelet count decreased
|
40.0%
4/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Investigations
Weight loss
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
8.9%
7/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
3/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
7.6%
6/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
60.0%
6/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
41.8%
33/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
8.9%
7/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Late RT Toxicity: joint: NOS
|
60.0%
6/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
38.0%
30/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
6.3%
5/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
50.6%
40/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Headache
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Neuralgia
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
10.1%
8/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
22.8%
18/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Phantom pain
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Speech disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Nervous system disorders
Taste alteration
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Psychiatric disorders
Depression
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Reproductive system and breast disorders
Gynecomastia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
7.6%
6/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
4/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
8.9%
7/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
2.5%
2/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
8.9%
7/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
11.4%
9/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
17.7%
14/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
50.0%
5/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
48.1%
38/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Hematoma
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
3.8%
3/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
0.00%
0/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Thrombosis
|
10.0%
1/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
5.1%
4/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
|
Vascular disorders
Vascular disorder
|
20.0%
2/10
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
1.3%
1/79
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER