Trial Outcomes & Findings for Cabozantinib in Advanced Solid Malignancies (NCT NCT01588821)

NCT ID: NCT01588821

Last Updated: 2020-09-29

Results Overview

Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: 8 Weeks
• Results posted on: 2020-09-29

Participant Flow

Participant milestones

Measure	Cabozantinib Cabozantinib: 60 mg daily by mouth
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cabozantinib n=37 Participants Cabozantinib: 60 mg daily by mouth
Age, Continuous	54.4 years n=37 Participants
Sex: Female, Male Female	14 Participants n=37 Participants
Sex: Female, Male Male	23 Participants n=37 Participants
Region of Enrollment United States	37 participants n=37 Participants
Diagnosis Sarcoma	14 Participants n=37 Participants
Diagnosis Renal Cell Carcinoma	7 Participants n=37 Participants
Diagnosis Non-Small cell lung cancer	5 Participants n=37 Participants
Diagnosis Head and neck carcinoma	4 Participants n=37 Participants
Diagnosis Thyroid Cancer	2 Participants n=37 Participants
Diagnosis Melanoma	2 Participants n=37 Participants
Diagnosis Adenoid Cystic Carcinoma	1 Participants n=37 Participants
Diagnosis Metastatic chondroblastoma	1 Participants n=37 Participants
Diagnosis Chordoma	1 Participants n=37 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Population: Only 19 participants were evaluable for determination of response by bone bio-markers

Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.

Outcome measures

Measure	Cabozantinib n=19 Participants Cabozantinib: 60 mg daily by mouth
Number of Participants With Bone Bio-marker Response Serum Ctx	13 Participants
Number of Participants With Bone Bio-marker Response Urine Ntx	9 Participants
Number of Participants With Bone Bio-marker Response Serum Ntx	8 Participants

SECONDARY outcome

Timeframe: 2 years

The number of patients that experience a SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)

Outcome measures

Measure	Cabozantinib n=37 Participants Cabozantinib: 60 mg daily by mouth
Number of Patients With Skeletal-related Events (SRE)	0 Participants

SECONDARY outcome

Timeframe: From baseline to Cycle 3 Day 1 (approximately 2 months)

Quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G assesses patients' physical, social/family, emotional, and functional well-being. The total score can range from 0 to 108, with lower scores indicating higher quality of life. Patients without QOL scores at cycle 3 day 1 had their score from their last assessment carried forward.

Outcome measures

Measure	Cabozantinib n=37 Participants Cabozantinib: 60 mg daily by mouth
Quality of Life as Assessed by FACT-G Baseline	56 units on a scale Interval 41.0 to 63.0
Quality of Life as Assessed by FACT-G Cycle 3 Day 1	56 units on a scale Interval 20.0 to 71.0

SECONDARY outcome

Timeframe: 2 years

Population: The 20 participants that were able to be evaluated for response. The other 17 participants had bone only disease

The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

• Complete Response (CR): Disappearance of all target lesions
• Partial Response (PR): At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD

Outcome measures

Measure	Cabozantinib n=20 Participants Cabozantinib: 60 mg daily by mouth
Overall Tumor Response Rate Complete Response	0 Participants
Overall Tumor Response Rate Partial Response	3 Participants

SECONDARY outcome

Timeframe: 2 years

Population: MET amplification testing was not done due to insufficient tumor material available for testing

Response will be correlated with specific tumor genotype (MET amplification).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Bone scan response assessment not done

Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: No SRE events occurred

Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)

Outcome measures

Outcome data not reported

Adverse Events

Cabozantinib

Serious events: 9 serious events

Other events: 37 other events

Deaths: 4 deaths

Serious adverse events

Measure	Cabozantinib n=37 participants at risk Cabozantinib: 60 mg daily by mouth
General disorders Fatigue	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Pain	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Abdominal pain	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Nausea	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Hepatobiliary disorders Cholecystitis	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Immune system disorders Allergic reaction	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Abdominal infection	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Lung infection	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Meningitis	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Nervous system disorders Dysgeusia	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Psychiatric disorders Anxiety	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.7% 1/37 • Number of events 1 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.

Other adverse events

Measure	Cabozantinib n=37 participants at risk Cabozantinib: 60 mg daily by mouth
Blood and lymphatic system disorders Anemia	21.6% 8/37 • Number of events 10 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Cardiac disorders Cardiac disorders - Other, specify	13.5% 5/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Edema limbs	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Fatigue	64.9% 24/37 • Number of events 42 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Fever	8.1% 3/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Flu like symptoms	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Malaise	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Endocrine disorders Hypothyroidism	29.7% 11/37 • Number of events 11 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Non-cardiac chest pain	10.8% 4/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders Pain	45.9% 17/37 • Number of events 21 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
General disorders General disorders and administration site conditions - Other,	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Skin and subcutaneous tissue disorders Alopecia	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	29.7% 11/37 • Number of events 16 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Skin and subcutaneous tissue disorders Pruritus	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Skin and subcutaneous tissue disorders Rash acneiform	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	35.1% 13/37 • Number of events 18 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Endocrine disorders Endocrine disorders - Other, specify	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Congenital, familial and genetic disorders Congenital, familial and genetic disorders - Other, specify	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Abdominal pain	8.1% 3/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hypertriglyceridemia	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Constipation	56.8% 21/37 • Number of events 22 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Diarrhea	48.6% 18/37 • Number of events 27 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Dry mouth	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Gastroesophageal reflux disease	32.4% 12/37 • Number of events 16 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Mucositis oral	8.1% 3/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Nausea	45.9% 17/37 • Number of events 23 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Oral dysesthesia	8.1% 3/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Oral pain	16.2% 6/37 • Number of events 6 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Vomiting	18.9% 7/37 • Number of events 7 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Hepatobiliary disorders Cholecystitis	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Meningitis	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Prostate infection	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Sinusitis	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Upper respiratory infection	13.5% 5/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Urinary tract infection	8.1% 3/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Infections and infestations Infections and infestations - Other, specify	13.5% 5/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Injury, poisoning and procedural complications Fracture	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Alanine aminotransferase increased	35.1% 13/37 • Number of events 15 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Alkaline phosphatase increased	27.0% 10/37 • Number of events 11 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Aspartate aminotransferase increased	51.4% 19/37 • Number of events 22 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations CPK increased	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Lipase increased	13.5% 5/37 • Number of events 8 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Platelet count decreased	13.5% 5/37 • Number of events 8 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Serum amylase increased	8.1% 3/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Weight loss	27.0% 10/37 • Number of events 14 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations White blood cell decreased	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Investigations Investigations - Other, specify	18.9% 7/37 • Number of events 8 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Anorexia	32.4% 12/37 • Number of events 17 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Dehydration	5.4% 2/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hyperglycemia	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hyperuricemia	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hypokalemia	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hypomagnesemia	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hyponatremia	5.4% 2/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Hypophosphatemia	29.7% 11/37 • Number of events 18 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	16.2% 6/37 • Number of events 7 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Arthritis	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Back pain	32.4% 12/37 • Number of events 17 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Bone pain	27.0% 10/37 • Number of events 10 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 2/37 • Number of events 7 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	18.9% 7/37 • Number of events 7 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder -	18.9% 7/37 • Number of events 9 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Nervous system disorders Dizziness	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Nervous system disorders Dysgeusia	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Nervous system disorders Headache	13.5% 5/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Nervous system disorders Peripheral sensory neuropathy	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Nervous system disorders Nervous system disorders - Other, specify	13.5% 5/37 • Number of events 6 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Eye disorders Glaucoma	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Eye disorders Eye disorders - Other, specify	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Psychiatric disorders Anxiety	13.5% 5/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Psychiatric disorders Depression	24.3% 9/37 • Number of events 9 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Psychiatric disorders Insomnia	32.4% 12/37 • Number of events 14 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Cough	21.6% 8/37 • Number of events 11 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.5% 5/37 • Number of events 5 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Hiccups	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Hoarseness	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Sore throat	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Renal and urinary disorders Hematuria	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Renal and urinary disorders Proteinuria	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Renal and urinary disorders Urinary frequency	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Renal and urinary disorders Renal and urinary disorders - Other, specify	16.2% 6/37 • Number of events 6 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Surgical and medical procedures Surgical and medical procedures - Other, specify	35.1% 13/37 • Number of events 13 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Reproductive system and breast disorders Erectile dysfunction	5.4% 2/37 • Number of events 2 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Vascular disorders Hypertension	62.2% 23/37 • Number of events 32 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Vascular disorders Hypotension	8.1% 3/37 • Number of events 3 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
Vascular disorders Thromboembolic event	10.8% 4/37 • Number of events 4 • Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis. Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.

Additional Information

Rebecca Suk Heist, MD

Massachusetts General Hospital

Phone: 617-724-4000

Email: rheist@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place