Trial Outcomes & Findings for Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer (NCT NCT02143726)
NCT ID: NCT02143726
Last Updated: 2026-02-11
Results Overview
Progression Free Survival (PFS) was defined as the time from randomization to the first of either disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
4 years and 4 months
Results posted on
2026-02-11
Participant Flow
Participant milestones
| Measure |
Arm 1 (Sorafenib)
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (Sorafenib and Everolimus)
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
Received Everolimus After Disease Progression
|
11
|
0
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Sorafenib)
n=16 Participants
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (Sorafenib and Everolimus)
n=17 Participants
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
65.6 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
65.5 years
STANDARD_DEVIATION 10.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=4 Participants
|
15 Participants
n=4 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=4 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=4 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 years and 4 monthsProgression Free Survival (PFS) was defined as the time from randomization to the first of either disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm 2 (Sorafenib and Everolimus)
n=17 Participants
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 1 (Sorafenib)
n=16 Participants
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival
|
24.7 Months
Interval 6.1 to 33.8
|
9.4 Months
Interval 5.5 to
Upper limit not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 4 years 4 monthsA patient will be classified as a confirmed response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm 2 (Sorafenib and Everolimus)
n=17 Participants
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 1 (Sorafenib)
n=16 Participants
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Confirmed Response Rate
|
0.235 Proportion of participants
|
0.188 Proportion of participants
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Arm 2 (Sorafenib and Everolimus)
n=17 Participants
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 1 (Sorafenib)
n=16 Participants
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
40.1 Months
Interval 38.2 to
Upper limit not reached due to insufficient number of participants with events
|
NA Months
Interval 25.7 to
Median and Upper limit not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 4 years 3 monthsThe maximum grade for each type of adverse event will be summarized using CTCAE version 4.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms.
Outcome measures
| Measure |
Arm 2 (Sorafenib and Everolimus)
n=17 Participants
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 1 (Sorafenib)
n=16 Participants
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
12 Participants
|
10 Participants
|
Adverse Events
Arm 1 (Sorafenib)
Serious events: 10 serious events
Other events: 17 other events
Deaths: 5 deaths
Arm 2 (Sorafenib and Everolimus)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm 1 (Sorafenib)
n=17 participants at risk
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (Sorafenib and Everolimus)
n=17 participants at risk
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Investigations
Weight loss
|
11.8%
2/17 • Number of events 5 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Eye disorders
Eye disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Infections and infestations
Gallbladder infection
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Infections and infestations
Kidney infection
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
Other adverse events
| Measure |
Arm 1 (Sorafenib)
n=17 participants at risk
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (Sorafenib and Everolimus)
n=17 participants at risk
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 4 • 4 years 3 months
|
11.8%
2/17 • Number of events 5 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 5 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.6%
3/17 • Number of events 3 • 4 years 3 months
|
41.2%
7/17 • Number of events 22 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
3/17 • Number of events 10 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
5.9%
1/17 • Number of events 5 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
70.6%
12/17 • Number of events 113 • 4 years 3 months
|
70.6%
12/17 • Number of events 94 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 5 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
76.5%
13/17 • Number of events 86 • 4 years 3 months
|
88.2%
15/17 • Number of events 165 • 4 years 3 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
|
Eye disorders
Cataract
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Gastrointestinal disorders
Bloating
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
76.5%
13/17 • Number of events 160 • 4 years 3 months
|
88.2%
15/17 • Number of events 140 • 4 years 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
11.8%
2/17 • Number of events 3 • 4 years 3 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Gastrointestinal disorders
Mucositis oral
|
23.5%
4/17 • Number of events 5 • 4 years 3 months
|
11.8%
2/17 • Number of events 7 • 4 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • 4 years 3 months
|
11.8%
2/17 • Number of events 10 • 4 years 3 months
|
|
General disorders
Edema limbs
|
5.9%
1/17 • Number of events 6 • 4 years 3 months
|
11.8%
2/17 • Number of events 3 • 4 years 3 months
|
|
General disorders
Facial pain
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
General disorders
Fatigue
|
88.2%
15/17 • Number of events 207 • 4 years 3 months
|
88.2%
15/17 • Number of events 222 • 4 years 3 months
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
General disorders
Pain
|
23.5%
4/17 • Number of events 9 • 4 years 3 months
|
11.8%
2/17 • Number of events 3 • 4 years 3 months
|
|
Hepatobiliary disorders
Cholecystitis
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Injury, poisoning and procedural complications
Injury to carotid artery
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 2 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Investigations
Cholesterol high
|
5.9%
1/17 • Number of events 6 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • 4 years 3 months
|
17.6%
3/17 • Number of events 9 • 4 years 3 months
|
|
Investigations
Neutrophil count decreased
|
23.5%
4/17 • Number of events 12 • 4 years 3 months
|
11.8%
2/17 • Number of events 3 • 4 years 3 months
|
|
Investigations
Platelet count decreased
|
58.8%
10/17 • Number of events 86 • 4 years 3 months
|
41.2%
7/17 • Number of events 46 • 4 years 3 months
|
|
Investigations
Weight loss
|
82.4%
14/17 • Number of events 133 • 4 years 3 months
|
76.5%
13/17 • Number of events 156 • 4 years 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
17.6%
3/17 • Number of events 10 • 4 years 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
76.5%
13/17 • Number of events 176 • 4 years 3 months
|
82.4%
14/17 • Number of events 131 • 4 years 3 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
11.8%
2/17 • Number of events 6 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/17 • 4 years 3 months
|
17.6%
3/17 • Number of events 3 • 4 years 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • 4 years 3 months
|
11.8%
2/17 • Number of events 4 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
2/17 • Number of events 12 • 4 years 3 months
|
11.8%
2/17 • Number of events 7 • 4 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.6%
3/17 • Number of events 4 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Nervous system disorders
Dysgeusia
|
11.8%
2/17 • Number of events 5 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
11.8%
2/17 • Number of events 4 • 4 years 3 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Renal and urinary disorders
Renal calculi
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Renal and urinary disorders
Urinary frequency
|
11.8%
2/17 • Number of events 4 • 4 years 3 months
|
11.8%
2/17 • Number of events 3 • 4 years 3 months
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Renal and urinary disorders
Urinary tract pain
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Renal and urinary disorders
Urinary urgency
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 3 • 4 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
11.8%
2/17 • Number of events 3 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
5.9%
1/17 • Number of events 1 • 4 years 3 months
|
0.00%
0/17 • 4 years 3 months
|
|
Vascular disorders
Hypertension
|
88.2%
15/17 • Number of events 233 • 4 years 3 months
|
94.1%
16/17 • Number of events 266 • 4 years 3 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/17 • 4 years 3 months
|
5.9%
1/17 • Number of events 2 • 4 years 3 months
|
Additional Information
Eric J. Sherman, M.D.
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place