Trial Outcomes & Findings for Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations (NCT NCT02296112)
NCT ID: NCT02296112
Last Updated: 2021-05-28
Results Overview
Per RECIST criteria version (v.) 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2021-05-28
Participant Flow
Participant milestones
| Measure |
Treatment (Trametinib)
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Treatment (Trametinib)
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
Disease progression
|
7
|
|
Overall Study
Toxicity
|
1
|
|
Overall Study
Began an alternate therapy
|
1
|
Baseline Characteristics
Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations
Baseline characteristics by cohort
| Measure |
Treatment (Trametinib)
n=9 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
52.111111111111 Years
STANDARD_DEVIATION 5.546381313885 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: patients with advanced melanoma with High Activity BRAF Mutations or Fusion Events.
Per RECIST criteria version (v.) 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=2 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Overall Response Rate in "High Affinity" Group
|
0.5 Proportion of participants
Interval 0.026 to 0.974
|
—
|
—
|
SECONDARY outcome
Timeframe: On-study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)Population: Patients with advanced melannoma with BRAF non-V600 mutations and received treatment
Progression of disease as defined by RECIST 1.1 criteria will be reported. Time from on treatment to progression or death (whichever comes first). For those did not progress or die, they were censored at the last follow up or off study date(if they do not have a last date of follow up).
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=9 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Progression-Free Survival All Patients
|
7.5 months
Interval 0.99 to
The upper bound for the 95% confidence interval is not estimable from the data.
|
—
|
—
|
SECONDARY outcome
Timeframe: Date of first partial or complete response as defined by RECIST 1.1 criteria to date of progression up to 3 yearsPopulation: Patients with advanced melanoma with BRAF "high activity"
Estimated probable duration from date of objective response to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>= 20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=2 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Duration of Response in "High Affinity" Group
|
NA months
Only 1 patient out of 2 had partial response on 6/7/2015. The patient was off study on 12/22/2015 due to alternative therapy and then the status was no longer known.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: patients with advanced melanoma with High Activity BRAF Mutations or Fusion Events.
Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=2 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Clinical Benefit (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD]) Per RECIST v. 1.1 in "High Affinity" Group
|
0.5 Proportion of participants
Interval 0.026 to 0.974
|
—
|
—
|
SECONDARY outcome
Timeframe: On-study date to date of death from any cause (assessed up to 3 years)Population: All patients on study
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=9 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Overall Survival
|
27.6 months
Interval 2.5 to
The upper bound is not estimable from the data.
|
—
|
—
|
SECONDARY outcome
Timeframe: On-study date to 30 days following final dose of study drug, up to 3 yearsPopulation: All patients on study.
Safety profile shown by count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per National Cancer Institute (NCI) common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=9 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
n=9 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
n=9 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Number of Patients With Each Worst-Grade Toxicity
|
2 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Patients on study with low activity
Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=7 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Overall Response Rate in "Low Affinity" Group
|
0.14 proportion
Interval 0.007 to 0.513
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Patients on study with low activity
Estimated probable duration from date of first partial or complete response as defined by RECIST 1.1 criteria to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>= 20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Outcome measures
| Measure |
Treatment (Trametinib) "High Activity"
n=7 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Worst Grade 2
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
Worst Grade 3
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
|
|---|---|---|---|
|
Duration of Response in "Low Affinity" Group
|
NA months
One patient started the treatment on 03/09/2019. Then had partial response. But the date was not known. Then the patient got off the treatment on 05/31/2018 due to toxicity.
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsPer RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsMolecular characterization of tumor tissue will be performed to identify markers that correlate with clinical responsiveness to treatment with trametinib. Optional on-treatment biopsies will be used to evaluate pharmacodynamic and other molecular effects of treatment, which will be compared to clinical outcomes. Optional post-progression samples will be analyzed to identify mechanisms of resistance.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Trametinib)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Trametinib)
n=9 participants at risk
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin infection
|
22.2%
2/9 • Number of events 3 • 39 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Limb edema
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Rash
|
11.1%
1/9 • Number of events 1 • 39 months
|
Other adverse events
| Measure |
Treatment (Trametinib)
n=9 participants at risk
Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
trametinib: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Cardiac disorders
Shortness of breath
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Burning sensation on the hands and ears
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
77.8%
7/9 • Number of events 11 • 39 months
|
|
Skin and subcutaneous tissue disorders
Rash, maculo-papular
|
55.6%
5/9 • Number of events 9 • 39 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
44.4%
4/9 • Number of events 4 • 39 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
3/9 • Number of events 3 • 39 months
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Number of events 3 • 39 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
7/9 • Number of events 20 • 39 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 3 • 39 months
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 3 • 39 months
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Xerosis
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
General disorders
Fatigue
|
66.7%
6/9 • Number of events 9 • 39 months
|
|
General disorders
Feeling cold all the time
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
face edema
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
General disorders
Pain
|
22.2%
2/9 • Number of events 3 • 39 months
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Flu-like symptoms
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Irritability
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
General disorders
Localized edema
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 3 • 39 months
|
|
Investigations
Creatinine increased
|
22.2%
2/9 • Number of events 4 • 39 months
|
|
Investigations
GGT increased
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Investigations
LDH Elevated
|
33.3%
3/9 • Number of events 4 • 39 months
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.4%
4/9 • Number of events 7 • 39 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
3/9 • Number of events 6 • 39 months
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 3 • 39 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Number of events 7 • 39 months
|
|
Blood and lymphatic system disorders
Hypokalemia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 3 • 39 months
|
|
Nervous system disorders
Loss of consciousness (for less than a minute during a fall)
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Nervous system disorders
Involuntary movements
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
3/9 • Number of events 5 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain (arm pit dull pain)
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
3/9 • Number of events 7 • 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Eye disorders
Blurred vision
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Infections and infestations
Tonsil infection
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Injury, poisoning and procedural complications
Fall
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Injury, poisoning and procedural complications
Seroma
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Psychiatric disorders
Anxiety
|
33.3%
3/9 • Number of events 3 • 39 months
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Vascular disorders
Lymphedema
|
33.3%
3/9 • Number of events 4 • 39 months
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Depression
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Bloating
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Bloating and gas pain
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Bruising
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Bumps in mouth
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
General disorders
Bumps in nose
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
General disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Headache
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
General disorders
Lumbar nerve root injury
|
11.1%
1/9 • Number of events 3 • 39 months
|
|
General disorders
Lymphedema
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Pain in right side chest
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Platelets elevated
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Investigations
Total white blood count elevated
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Hyperlipidemia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Investigations
Vitamin D deficiency
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
11.1%
1/9 • Number of events 3 • 39 months
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
11.1%
1/9 • Number of events 2 • 39 months
|
|
Blood and lymphatic system disorders
Hypergylcemia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Blood and lymphatic system disorders
ALT 402 U/L
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Blood and lymphatic system disorders
AST 170 U/L
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Infections and infestations
Toe fungus
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Infections and infestations
Thrush
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Pain in left upper extremity
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Soft tissue infection in left arm
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
3rd finger amputation
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Leg spasm
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Mucositis
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Gastrointestinal disorders
Xerostemia
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Skin and subcutaneous tissue disorders
New skin lesion
|
22.2%
2/9 • Number of events 2 • 39 months
|
|
Skin and subcutaneous tissue disorders
Toe fungus
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Skin and subcutaneous tissue disorders
Red elevated papule under the right axilla
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New basal cell carcinoma right flank
|
11.1%
1/9 • Number of events 1 • 39 months
|
|
Nervous system disorders
Intermittent head pressure
|
11.1%
1/9 • Number of events 1 • 39 months
|
Additional Information
Douglas Johnson, MD
Vanderbilt University Medical Center
Phone: (615) 936-8422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place