Trial Outcomes & Findings for Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT00301964)
NCT ID: NCT00301964
Last Updated: 2019-07-24
Results Overview
Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-24
Participant Flow
Participant milestones
| Measure |
Treatment (Bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Second primary
|
2
|
|
Overall Study
Wrong primary
|
1
|
|
Overall Study
Inadequate pathology
|
1
|
Baseline Characteristics
Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
|
Age, Customized
30-39 years
|
1 participants
n=99 Participants
|
|
Age, Customized
40-49 years
|
4 participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
13 participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
22 participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
11 participants
n=99 Participants
|
|
Age, Customized
80-89 years
|
1 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
|
Cell Type
Adenocarcinoma, Unspecified
|
1 participants
n=99 Participants
|
|
Cell Type
Clear Cell Carcinoma
|
4 participants
n=99 Participants
|
|
Cell Type
Endometrioid Adenocarcinoma
|
26 participants
n=99 Participants
|
|
Cell Type
Mucinous Adenocarcinoma
|
1 participants
n=99 Participants
|
|
Cell Type
Mixed Epithelial Carcinoma
|
5 participants
n=99 Participants
|
|
Cell Type
Undifferentiated Carcinoma
|
1 participants
n=99 Participants
|
|
Cell Type
Serous Adenocarcinoma
|
14 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Total number of eligible and evaluable participants
Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival Greater Than 6 Months
No
|
31 participants
|
—
|
—
|
—
|
—
|
—
|
|
Progression-free Survival Greater Than 6 Months
Yes
|
21 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: study entry through completionPopulation: Total number eligible and evaluable participants
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Best Tumor Response
Complete Response
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Best Tumor Response
Partial Response
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
|
Best Tumor Response
Stable Disease
|
26 participants
|
—
|
—
|
—
|
—
|
—
|
|
Best Tumor Response
Disease Progression
|
17 participants
|
—
|
—
|
—
|
—
|
—
|
|
Best Tumor Response
Indeterminate
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and treated patients
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
n=52 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=52 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=52 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=52 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
n=52 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Hypertension
|
43 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Hypotension
|
50 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Other Cardiac
|
48 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Leukopenia
|
48 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Thrombocytopenia
|
46 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Neutropenia
|
50 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Anemia
|
36 Participants
|
9 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Constitutional
|
17 Participants
|
23 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Pain
|
33 Participants
|
11 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Hypersensitivity
|
50 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Rhinitis
|
50 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Dermatologic
|
47 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Nausea
|
44 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Vomiting
|
46 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
GI
|
28 Participants
|
21 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Hemorrhage
|
40 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Hepatobiliary
|
51 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Infection
|
47 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Edema (limb)
|
48 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Metabolic
|
30 Participants
|
16 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Musculoskeletal
|
48 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Neurosensory
|
48 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Other neurologic
|
47 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Ocular/visual
|
49 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.Population: Eligible and treated patients.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
4.17 months
Interval 1.38 to 8.57
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.Population: Eligible and treated patients.
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
10.55 months
Interval 6.6 to 24.28
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Initial Performance Status
Performance Status 2
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Initial Performance Status
Performance Status 0
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Initial Performance Status
Performance Status 1
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.
Outcome measures
| Measure |
Treatment (Bevacizumab)
n=52 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Histologic Grade
Grade 1
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Histologic Grade
Grade 2
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Histologic Grade
Grade 3
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (Bevacizumab)
Serious events: 18 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Bevacizumab)
n=52 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypotension
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Obstruction, Gi - Rectum
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Pulmonary - Lung
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Extremity-Limb
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Abdominal Pain Nos
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
Other adverse events
| Measure |
Treatment (Bevacizumab)
n=52 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Immune system disorders
Rhinitis
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Neutrophils
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Platelets
|
13.5%
7/52 • from study entry up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Leukocytes
|
15.4%
8/52 • from study entry up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
46.2%
24/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
Palpitations
|
9.6%
5/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Tachycardia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypertension
|
23.1%
12/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypotension
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Inr
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Sweating
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Weight Gain
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Fever
|
11.5%
6/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Weight Loss
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Rigors/Chills
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Fatigue
|
73.1%
38/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Insomnia
|
15.4%
8/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
17.3%
9/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
8/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hot Flashes
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gastritis
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Heartburn
|
11.5%
6/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Esophagus
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Distention
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Taste Alteration
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
19.2%
10/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
11.5%
6/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
12/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Anorexia
|
21.2%
11/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dehydration
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
28.8%
15/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
36.5%
19/52 • from study entry up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
32.7%
17/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
11.5%
6/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Pulmonary - Respiratory Tract Nos
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
11.5%
6/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vein
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Mucosa
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Oral Cavity-Gums
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Edema: Limb
|
13.5%
7/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Ast
|
15.4%
8/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Proteinuria
|
9.6%
5/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Creatinine
|
17.3%
9/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.7%
17/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Ggt
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alt
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
17.3%
9/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Lipase
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.8%
15/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Amylase
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.2%
10/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
26.9%
14/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.2%
11/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Cervical Spine Rom
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Involuntary Movement
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Depression
|
13.5%
7/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
13.5%
7/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Memory Impairment
|
9.6%
5/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Dizziness
|
9.6%
5/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Sensory
|
25.0%
13/52 • from study entry up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Motor
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Eye disorders
Ocular/Visual - Other
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Eye disorders
Dry Eye
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Eye disorders
Photophobia
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Eye disorders
Flashing Lights/Floaters
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Eye disorders
Blurred Vision
|
13.5%
7/52 • from study entry up to 5 years after stopping study treatment
|
|
Eye disorders
Eyelid Dysfunction
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain - Other
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Pelvis
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest /Thorax Nos
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest Wall
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Head/Headache
|
30.8%
16/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Neck
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Extremity-Limb
|
17.3%
9/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Buttock
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Back
|
19.2%
10/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Joint
|
11.5%
6/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Bone
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Stomach
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Rectum
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Abdominal Pain Nos
|
25.0%
13/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Muscle
|
9.6%
5/52 • from study entry up to 5 years after stopping study treatment
|
|
General disorders
Pain: Neuralgia
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
7.7%
4/52 • from study entry up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
12/52 • from study entry up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.7%
17/52 • from study entry up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Leak, Gu - Urethra
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Retention
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Incontinence, Urinary
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Frequency
|
5.8%
3/52 • from study entry up to 5 years after stopping study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx
|
1.9%
1/52 • from study entry up to 5 years after stopping study treatment
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
3.8%
2/52 • from study entry up to 5 years after stopping study treatment
|
Additional Information
Jessalyn Reboy
NRG Oncology, Statistics and Data Management Center, Buffalo Office
Phone: 716-845-7738
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60