Trial Outcomes & Findings for Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (NCT NCT02971761)
NCT ID: NCT02971761
Last Updated: 2024-02-20
Results Overview
Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2024-02-20
Participant Flow
Patients seen at the City of Hope main campus and its surrounding affiliated community clinics.
Study was conducted from June 1, 2017 to October 28, 2019.
Participant milestones
| Measure |
Treatment (Pembrolizumab, Enobosarm)
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, Enobosarm)
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
GTx-024 drug supply was withdrawn
|
2
|
Baseline Characteristics
Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic White
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Number of previous lines of therapy
Received 0-1 previous lines of therapy
|
9 Participants
n=5 Participants
|
|
Number of previous lines of therapy
Received >=2 previous lines of therapy
|
7 Participants
n=5 Participants
|
|
Performance Status (ECOG)
ECOG stage 0
|
7 Participants
n=5 Participants
|
|
Performance Status (ECOG)
ECOG stage 1
|
9 Participants
n=5 Participants
|
|
Nottingham Histological grade
Grade 1
|
2 Participants
n=5 Participants
|
|
Nottingham Histological grade
Grade 2
|
5 Participants
n=5 Participants
|
|
Nottingham Histological grade
Grade 3
|
9 Participants
n=5 Participants
|
|
Initial tumor stage
Stage I
|
6 Participants
n=5 Participants
|
|
Initial tumor stage
Stage II
|
8 Participants
n=5 Participants
|
|
Initial tumor stage
Stage III
|
2 Participants
n=5 Participants
|
|
Prior surgery
Lumpectomy
|
7 Participants
n=5 Participants
|
|
Prior surgery
Mastectomy
|
9 Participants
n=5 Participants
|
|
Prior radiation
Yes, received prior radiation
|
15 Participants
n=5 Participants
|
|
Prior radiation
No
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsResponse rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Response Rate (Complete Response or Partial Response)
Complete response
|
1 Participants
|
|
Response Rate (Complete Response or Partial Response)
Partial response
|
1 Participants
|
|
Response Rate (Complete Response or Partial Response)
Stable disease
|
2 Participants
|
|
Response Rate (Complete Response or Partial Response)
Progressive disease
|
12 Participants
|
SECONDARY outcome
Timeframe: Time to disease progression/relapse or death as a result of any cause, assessed up to 36 monthsProgression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival
|
2.6 months
Interval 1.9 to 3.1
|
SECONDARY outcome
Timeframe: At 16 weeksClinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Clinical Benefit Rate
|
4 Participants
|
SECONDARY outcome
Timeframe: Time to death as a result of any cause, assessed up to 36 monthsOverall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival
|
25.5 months
Interval 10.4 to 30.9
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Two patients were not evaluable for response, and were excluded from progression-free survival.
Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival
|
2.6 months
Interval 1.9 to 3.1
|
Adverse Events
Treatment (Pembrolizumab, Enobosarm)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=18 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Cardiac disorders
10019279-Heart failure
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10021038-Hyponatremia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10016750-Flank pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10001409-Adult respiratory distress syndrome
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10013963-Dyspnea
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Enobosarm)
n=18 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Enobosarm: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
10002272-Anemia
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Cardiac disorders
10033557-Palpitations
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Cardiac disorders
10040741-Sinus bradycardia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Cardiac disorders
10040752-Sinus tachycardia
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Cardiac disorders
bradypnea
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Ear and labyrinth disorders
10014020-Ear pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Endocrine disorders
10001367-Adrenal insufficiency
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Endocrine disorders
10020850-Hyperthyroidism
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Endocrine disorders
10021114-Hypothyroidism
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Eye disorders
10005886-Blurred vision
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Eye disorders
eye discomfort
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10000060-Abdominal distension
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10000081-Abdominal pain
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10005265-Bloating
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10010774-Constipation
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10012318-Dental caries
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10012727-Diarrhea
|
44.4%
8/18 • Number of events 8 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10013781-Dry mouth
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10013946-Dyspepsia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10013950-Dysphagia
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10015388-Esophageal pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10016766-Flatulence
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10017999-Gastrointestinal pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10028813-Nausea
|
33.3%
6/18 • Number of events 6 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
10047700-Vomiting
|
33.3%
6/18 • Number of events 6 • 36 months from commencement of treatment
|
|
Gastrointestinal disorders
discomfort
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
General disorders
10008531-Chills
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
General disorders
10011914-Death NOS
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
General disorders
10014222-Edema face
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
General disorders
10016059-Facial pain
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
General disorders
10016256-Fatigue
|
72.2%
13/18 • Number of events 13 • 36 months from commencement of treatment
|
|
General disorders
10016558-Fever
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
General disorders
10017577-Gait disturbance
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
General disorders
10022095-Injection site reaction
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
General disorders
10033371-Pain
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
General disorders
10050068-Edema limbs
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
General disorders
10062466-Localized edema
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
General disorders
10062501-Non-cardiac chest pain
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
General disorders
DROWSINESS
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Immune system disorders
10001718-Allergic reaction
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Infections and infestations
10005047-Bladder infection
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Infections and infestations
10046300-Upper respiratory infection
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Infections and infestations
10046571-Urinary tract infection
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Infections and infestations
10048038-Wound infection
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Infections and infestations
stomach flu
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Injury, poisoning and procedural complications
10016173-Fall
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Injury, poisoning and procedural complications
10041569-Spinal fracture
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Investigations
10001551-Alanine aminotransferase increased
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Investigations
10003481-Aspartate aminotransferase increased
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Investigations
10008661-Cholesterol high
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Investigations
10011368-Creatinine increased
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Investigations
10025256-Lymphocyte count decreased
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Investigations
10029366-Neutrophil count decreased
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Investigations
10035528-Platelet count decreased
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Investigations
10047896-Weight gain
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Investigations
10047900-Weight loss
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Investigations
10049182-White blood cell decreased
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10002646-Anorexia
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10020639-Hyperglycemia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10020647-Hyperkalemia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10020943-Hypoalbuminemia
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10020949-Hypocalcemia
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10021005-Hypoglycemia
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10021018-Hypokalemia
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10021028-Hypomagnesemia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10021038-Hyponatremia
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
10021059-Hypophosphatemia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Metabolism and nutrition disorders
INCREASED TRIGLYCERIDES
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10003239-Arthralgia
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10003988-Back pain
|
33.3%
6/18 • Number of events 6 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10006002-Bone pain
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10008496-Chest wall pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10016750-Flank pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10028411-Myalgia
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10028836-Neck pain
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10033425-Pain in extremity
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
10062572-Generalized muscle weakness
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MSK PAIN
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER PAIN
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP PAIN
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE PAIN
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
RIGHT THIGH PAIN
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
increased muscle mass
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Musculoskeletal and connective tissue disorders
muscle spasms (back)
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
actinic keratosis, hyperplastic
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
progressive disease
|
33.3%
6/18 • Number of events 6 • 36 months from commencement of treatment
|
|
Nervous system disorders
10013573-Dizziness
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Nervous system disorders
10013911-Dysgeusia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Nervous system disorders
10019211-Headache
|
50.0%
9/18 • Number of events 9 • 36 months from commencement of treatment
|
|
Nervous system disorders
10020765-Hypersomnia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Nervous system disorders
10024264-Lethargy
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Nervous system disorders
10034620-Peripheral sensory neuropathy
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Nervous system disorders
10041349-Somnolence
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Nervous system disorders
10044565-Tremor
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Psychiatric disorders
10002855-Anxiety
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Psychiatric disorders
10012378-Depression
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Psychiatric disorders
10022437-Insomnia
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Psychiatric disorders
10024419-Libido decreased
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
10019450-Hematuria
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
10037032-Proteinuria
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
10046539-Urinary frequency
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
10046593-Urinary urgency
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
10061574-Urinary tract obstruction
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
10063057-Cystitis noninfective
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Renal and urinary disorders
oliguria (mild)
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Reproductive system and breast disorders
10006298-Breast pain
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Reproductive system and breast disorders
10046904-Vaginal dryness
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10003504-Aspiration
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10011224-Cough
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10013963-Dyspnea
|
38.9%
7/18 • Number of events 7 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10015090-Epistaxis
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10021143-Hypoxia
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10028735-Nasal congestion
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10035598-Pleural effusion
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10036402-Postnasal drip
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10036790-Productive cough
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10041367-Sore throat
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
10047924-Wheezing
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE PNEUMONIA
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
bilateral pneumonia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Respiratory, thoracic and mediastinal disorders
rhonchi breath sounds
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10001760-Alopecia
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10013786-Dry skin
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10020642-Hyperhidrosis
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10033474-Pain of skin
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10037087-Pruritus
|
22.2%
4/18 • Number of events 4 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10037847-Rash acneiform
|
16.7%
3/18 • Number of events 3 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10037868-Rash maculo-papular
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Skin and subcutaneous tissue disorders
10054541-Periorbital edema
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Surgical and medical procedures
stent placement
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Vascular disorders
10016825-Flushing
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Vascular disorders
10020407-Hot flashes
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Vascular disorders
10020772-Hypertension
|
66.7%
12/18 • Number of events 12 • 36 months from commencement of treatment
|
|
Vascular disorders
10021097-Hypotension
|
27.8%
5/18 • Number of events 5 • 36 months from commencement of treatment
|
|
Vascular disorders
10025233-Lymphedema
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
|
Vascular disorders
10042554-Superficial thrombophlebitis
|
5.6%
1/18 • Number of events 1 • 36 months from commencement of treatment
|
|
Vascular disorders
10043565-Thromboembolic event
|
11.1%
2/18 • Number of events 2 • 36 months from commencement of treatment
|
Additional Information
Yuan Yuan, MD, PhD.
Department of Medical Oncology, City of Hope
Phone: 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place