Trial Outcomes & Findings for Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate (NCT NCT02581839)
NCT ID: NCT02581839
Last Updated: 2020-07-30
Results Overview
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
At 12 weeks
Results posted on
2020-07-30
Participant Flow
Participant milestones
| Measure |
Eribulin Mesylate
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Age, Customized
years · 20-29
|
0 Participants
n=5 Participants
|
|
Age, Customized
years · 30-39
|
3 Participants
n=5 Participants
|
|
Age, Customized
years · 40-49
|
0 Participants
n=5 Participants
|
|
Age, Customized
years · 50-59
|
3 Participants
n=5 Participants
|
|
Age, Customized
years · 60-69
|
1 Participants
n=5 Participants
|
|
Age, Customized
years · 70-79
|
1 Participants
n=5 Participants
|
|
Age, Customized
years · 80-89
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
1 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
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksThe study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
|
88.9 percentage of participants
Interval 51.0 to 99.7
|
SECONDARY outcome
Timeframe: up to 2 years from start of treatmentThe study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Objective Response Rate (RR)
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 years from start of treatmentThe study team will calculate the duration of CNS response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Median Duration of CNS Response
|
22.6 weeks
Interval 4.3 to 31.9
|
SECONDARY outcome
Timeframe: up to 2 years from start of treatmentThe study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events
|
3 Participants
|
SECONDARY outcome
Timeframe: At 12 weeksThe study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Number of Patients With CBR
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 2 years from start of treatmentPopulation: Data not collected due to too few participants on study for a significant length of time
The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 years from start of treatmentThe study team will generate a Kaplan-Meier curve of OS.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Median Overall Survival (OS)
|
15.7 months
Interval 4.0 to 27.3
|
Adverse Events
Eribulin Mesylate
Serious events: 3 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Eribulin Mesylate
n=9 participants at risk
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Infections and infestations
Lung infection
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
worsening pseudomeningeocele
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
Other adverse events
| Measure |
Eribulin Mesylate
n=9 participants at risk
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
6/9 • Number of events 11 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Eye disorders
Aura
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Eye disorders
Neuro; Other- perception/focus
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Eye disorders
Vision Change
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • Number of events 8 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • Number of events 12 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
3/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 9 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Edema face
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Edema limbs
|
33.3%
3/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Fatigue
|
88.9%
8/9 • Number of events 27 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Gait disturbance
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Malaise
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Non-cardiac chest pain
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Infections and infestations
Lung infection
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Infections and infestations
Rhinitis infective
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Injury, poisoning and procedural complications
Fall
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
3/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Lymphocyte count decreased
|
55.6%
5/9 • Number of events 20 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Neutrophil count decreased
|
33.3%
3/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
Platelet count decreased
|
44.4%
4/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Investigations
White blood cell decreased
|
66.7%
6/9 • Number of events 16 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
3/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.2%
2/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
2/9 • Number of events 5 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
2/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.1%
1/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
22.2%
2/9 • Number of events 10 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint range motion decreased
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Lock jaw
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
44.4%
4/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Ataxia
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Dizziness
|
44.4%
4/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Dysgeusia
|
33.3%
3/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Memory impairment
|
33.3%
3/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
L carpel tunnel
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
woozy feeling
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Oculomotor nerve disorder
|
11.1%
1/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
44.4%
4/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
3/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Renal and urinary disorders
Urinary urgency
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
4/9 • Number of events 7 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.4%
4/9 • Number of events 6 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Skin and subcutaneous tissue disorders
folliculitis
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Vascular disorders
Hypertension
|
33.3%
3/9 • Number of events 4 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Vascular disorders
Lymphedema
|
22.2%
2/9 • Number of events 2 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Vascular disorders
Thromboembolic event
|
22.2%
2/9 • Number of events 3 • 30 days after treatment has been discontinued, an average of 5 months
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
1/9 • Number of events 1 • 30 days after treatment has been discontinued, an average of 5 months
|
Additional Information
Dr. Paula Silverman
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 1-800-641-2422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place