Trial Outcomes & Findings for Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer (NCT NCT02203552)
NCT ID: NCT02203552
Last Updated: 2025-01-08
Results Overview
CES-D scale a short self-reported scaled designed to measure depressive symptomology in the general population. At baseline, depressive symptom severity will be assessed using the CES-D instrument. Evaluation of the patients assessment if suicidal ideation is reported at baseline. A value of 0, 1, 2, or 3 is assigned to a response depending upon positively or negatively. The subject will be withdrawn from the administrated serially every cycle starts on protocol during clinic visits (Patients will self-administer forms given out by research coordinator).The internal consistency for the STAI is .95; higher scores indicate greater anxiety.41 The internal consistency for the CES-D is approximately .85 among BC patients,42 and an important benefit of using this scale in medical studies is that it is relatively unaffected by physical symptoms. Total scores range from 0-60 with higher scores reflecting greater depressive symptoms. The 95% confidence intervals of the depression change from b
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline to 9 weeks
Results posted on
2025-01-08
Participant Flow
Recruitment was from June 2015 until June 2020
Participant milestones
| Measure |
Arm I (Minocycline Hydrochloride)
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride: 100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Arm II (Placebo)
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo: Placebo given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Minocycline Hydrochloride)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride: 100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Arm II (Placebo)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo: Placebo given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 9 weeksCES-D scale a short self-reported scaled designed to measure depressive symptomology in the general population. At baseline, depressive symptom severity will be assessed using the CES-D instrument. Evaluation of the patients assessment if suicidal ideation is reported at baseline. A value of 0, 1, 2, or 3 is assigned to a response depending upon positively or negatively. The subject will be withdrawn from the administrated serially every cycle starts on protocol during clinic visits (Patients will self-administer forms given out by research coordinator).The internal consistency for the STAI is .95; higher scores indicate greater anxiety.41 The internal consistency for the CES-D is approximately .85 among BC patients,42 and an important benefit of using this scale in medical studies is that it is relatively unaffected by physical symptoms. Total scores range from 0-60 with higher scores reflecting greater depressive symptoms. The 95% confidence intervals of the depression change from b
Outcome measures
| Measure |
Arm I (Minocycline Hydrochloride)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride: 100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Arm II (Placebo)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo: Placebo given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
|---|---|---|
|
Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores
|
0.57 score on a scale
Interval -2.87 to 4.0
|
-3.18 score on a scale
Interval -6.4 to 0.03
|
PRIMARY outcome
Timeframe: Baseline to 9 weeksThe mean changes over time in State Trait Anxiety Index (STAI) scores from baseline to the end of study for the two study groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses. The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).The 95% confidence intervals of the change in the primary outcome measures from baseline to the end of study and the differences between the treatment and placebo groups will be estimated based on the models.
Outcome measures
| Measure |
Arm I (Minocycline Hydrochloride)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride: 100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Arm II (Placebo)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo: Placebo given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
|---|---|---|
|
Changes in the State Trait Anxiety Index (STAI) Scores
|
-5.86 scores on a scale
Interval -11.69 to -0.04
|
-9.41 scores on a scale
Interval -16.38 to -2.44
|
SECONDARY outcome
Timeframe: Baseline to 9 weeksPopulation: Data was not collected and analyzed
The 95% confidence intervals of the anxiety change from baseline to the end of study and the difference between the treatment and placebo groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses. In addition, change overtime of all outcomes for each individual will be plotted to visually explore any patterns and to generate hypothesis to be tested in future studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 9 weeksPopulation: Data not collected or analyzed
The 95% confidence intervals of the depression change from baseline to the end of study and the difference between the treatment and placebo groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses. In addition, change overtime of all outcomes for each individual will be plotted to visually explore any patterns and to generate hypothesis to be tested in future studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 monthsScatter plots will be used to explore the pair-wise correlation among the changes of CES-D and STAI scores, blood biomarkers changes, and PET/MRI measures. A statistical model will be used to explore whether the blood based biomarkers and PET/MRI measures can be used to predict the changes in CES-D and STAI scores, which then could be used as potential surrogate markers in future studies.
Outcome measures
| Measure |
Arm I (Minocycline Hydrochloride)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride: 100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Arm II (Placebo)
n=28 Participants
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo: Placebo given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
|---|---|---|
|
Changes in Inflammatory Blood Markers
IL-1b
|
0.04 pg/ml
Interval -0.2 to 0.29
|
0 pg/ml
Interval -0.13 to 0.12
|
|
Changes in Inflammatory Blood Markers
IL-6
|
0.17 pg/ml
Interval 0.05 to 0.39
|
0.26 pg/ml
Interval 0.12 to 0.41
|
|
Changes in Inflammatory Blood Markers
IL-8
|
0.07 pg/ml
Interval -0.04 to 0.19
|
0.14 pg/ml
Interval 0.01 to 0.27
|
|
Changes in Inflammatory Blood Markers
TNF-a
|
0.18 pg/ml
Interval 0.05 to 0.32
|
0.11 pg/ml
Interval -0.01 to 0.22
|
|
Changes in Inflammatory Blood Markers
TNF-RII
|
0.11 pg/ml
Interval 0.04 to 0.17
|
0.06 pg/ml
Interval 0.02 to 0.1
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Data not collected and analyzed
Scatter plots will be used to explore the pair-wise correlation among the changes of CES-D and STAI scores, blood biomarkers changes, and PET/MRI measures. A statistical model will be used to explore whether the blood based biomarkers and PET/MRI measures can be used to predict the changes in CES-D and STAI scores, which then could be used as potential surrogate markers in future studies.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Minocycline Hydrochloride)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Minocycline Hydrochloride)
n=28 participants at risk
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride: 100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
Arm II (Placebo)
n=28 participants at risk
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo: Placebo given by mouth for 9 weeks
laboratory biomarker analysis: Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration: The CES-D and STAI will be administrated weekly.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
100.0%
28/28 • Number of events 28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
100.0%
28/28 • Number of events 28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
78.6%
22/28 • Number of events 22 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
75.0%
21/28 • Number of events 21 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
28/28 • Number of events 28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
100.0%
28/28 • Number of events 28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
General disorders
Fatigue
|
64.3%
18/28 • Number of events 18 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
78.6%
22/28 • Number of events 22 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Nausea
|
64.3%
18/28 • Number of events 18 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
67.9%
19/28 • Number of events 19 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
8/28 • Number of events 8 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
32.1%
9/28 • Number of events 9 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Psychiatric disorders
Anxiety
|
35.7%
10/28 • Number of events 10 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
46.4%
13/28 • Number of events 13 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Nervous system disorders
Headache
|
39.3%
11/28 • Number of events 11 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
50.0%
14/28 • Number of events 14 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Mucositis
|
28.6%
8/28 • Number of events 8 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
46.4%
13/28 • Number of events 13 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Constipation
|
35.7%
10/28 • Number of events 10 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
35.7%
10/28 • Number of events 10 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Nervous system disorders
Dizziness
|
39.3%
11/28 • Number of events 11 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
35.7%
10/28 • Number of events 10 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
42.9%
12/28 • Number of events 12 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
8/28 • Number of events 8 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
39.3%
11/28 • Number of events 11 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
General disorders
Pain
|
39.3%
11/28 • Number of events 11 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
35.7%
10/28 • Number of events 10 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
General disorders
Edema Limbs
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
42.9%
12/28 • Number of events 12 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
32.1%
9/28 • Number of events 9 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
28.6%
8/28 • Number of events 8 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Psychiatric disorders
Depression
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Psychiatric disorders
Insomnia
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
28.6%
8/28 • Number of events 8 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
28.6%
8/28 • Number of events 8 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
7/28 • Number of events 7 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Vascular disorders
Hot Flashes
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Epistaxis
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
10.7%
3/28 • Number of events 3 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
10.7%
3/28 • Number of events 3 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
General disorders
Fever
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
10.7%
3/28 • Number of events 3 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Investigations
Platelet count decreased
|
7.1%
2/28 • Number of events 2 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
2/28 • Number of events 2 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.7%
3/28 • Number of events 3 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Immune system disorders
Hypothyroidism
|
0.00%
0/28 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
21.4%
6/28 • Number of events 6 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Nervous system disorders
Paresthesia
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
17.9%
5/28 • Number of events 5 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Immune system disorders
Arthritis
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
14.3%
4/28 • Number of events 4 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
10.7%
3/28 • Number of events 3 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
7.1%
2/28 • Number of events 2 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Eye disorders
Eye disorders
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
7.1%
2/28 • Number of events 2 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
7.1%
2/28 • Number of events 2 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
7.1%
2/28 • Number of events 2 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
3.6%
1/28 • Number of events 1 • Toxicity will be monitored from the beginning of the study through study follow-up, an average of 1 year.
Toxicity will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) of the National Cancer Institute will be used Grade 3, 4 and 5 toxicities will be reported as adverse events.
|
Additional Information
Dr. Bhuvaneswari Ramaswamy
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-7484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place