Trial Outcomes & Findings for Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma (NCT NCT02107755)
NCT ID: NCT02107755
Last Updated: 2024-05-21
Results Overview
Calculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Time of study enrollment until the first documented date of disease progression, assessed up to 6 months
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 Participants
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Time of study enrollment until the first documented date of disease progression, assessed up to 6 monthsCalculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used.
Outcome measures
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 Participants
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Rate of Progression-free Survival by mWHO Criteria
|
0.75 months
Interval 0.31 to 0.93
|
SECONDARY outcome
Timeframe: Time of study enrollment until the first documented date of disease progression, assessed up to 6 monthsCalculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used.
Outcome measures
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 Participants
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Rate of Progression-free Survival by irRC Criteria
|
0.75 months
Interval 0.31 to 0.93
|
SECONDARY outcome
Timeframe: Up to 90 days after the last ipilimumab infusionFrequency and severity of adverse events and tolerability of the regimen in each of the patient groups will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Outcome measures
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 Participants
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Thromboembolic event
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Alanine aminotransferase increased
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Anemia
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Aspartate aminotransferase increased
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Diarrhea
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Generalized muscle weakness
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Hypernatremia
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Hypertension
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Lymphedema
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Musculoskeletal and connective tissue disorder - Other, specify
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Platelet count decreased
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Rash maculo-papular
|
1 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4
Hyponatremia
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Data was not collected and analyzed for the study
The response rate evaluated based on mWHO \& irRC criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Data was not collected and analyzed for the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time of study enrollment until the first documented date of failure within the irradiated field, assessed up to 10 yearsPopulation: Data was not collected and analyzed for the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time of study enrollment until the time of death, assessed up to 6 yearsKaplan-Meier curves will be used.
Outcome measures
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 Participants
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Rate of Overall Survival
|
0.83 months
Interval 0.27 to 0.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 50Population: Data not collected and analyzed for the study
Summarized univariately in a quantitative manner and also summarized by clinical outcome group (e.g. prog-free and alive at 6 months vs. not). Graphical analyses will be largely used to assess potential patterns and relationships; e.g. side-by-side boxplots to assess differences.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ipilimumab, Stereotactic Radiosurgery)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 participants at risk
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal and Connective Tissue Disorder
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
Other adverse events
| Measure |
Treatment (Ipilimumab, Stereotactic Radiosurgery)
n=8 participants at risk
Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.
ipilimumab: Given IV
stereotactic radiosurgery: Undergo stereotactic radiosurgery
laboratory biomarker analysis: Blood and tissue samples will be collected for research purposes.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Immune system disorders
Allergic reaction
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
5/8 • Number of events 5 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Eye disorders
Blurred vision
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Investigations
Cardiac troponin I increased
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Investigations
Cardiac troponin T increased
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Nervous system disorders
Dysgeusia
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 5 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
General disorders
Flu like symptoms
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Vascular disorders
Hot flashes
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Lymphedema
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 6 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected from the start of the study through the completion of the study which was up to an average of 5 years.
The National Cancer Insitutes CTCAE version 4 was used to grade all adverse events.
|
Additional Information
Dr. Jose Bazan
The Ohio State University Comprehensive Cancer Center
Phone: 614-688-7040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place