Trial Outcomes & Findings for Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma (NCT NCT02243605)

NCT ID: NCT02243605

Last Updated: 2025-08-08

Results Overview

Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1. As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: At 6 months
• Results posted on: 2025-08-08

Participant Flow

Participant milestones

Measure	Ewing Sarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.	Osteosarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Stage 1 - Interim Analysis Population STARTED	23	22
Stage 1 - Interim Analysis Population COMPLETED	21	21
Stage 1 - Interim Analysis Population NOT COMPLETED	2	1
Stage 2 - Final Analysis Population STARTED	45	45
Stage 2 - Final Analysis Population COMPLETED	39	42
Stage 2 - Final Analysis Population NOT COMPLETED	6	3

Reasons for withdrawal

Measure	Ewing Sarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.	Osteosarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Stage 1 - Interim Analysis Population Protocol Violation	1	1
Stage 1 - Interim Analysis Population Adverse Event	1	0
Stage 2 - Final Analysis Population Protocol Violation	5	1
Stage 2 - Final Analysis Population Adverse Event	1	1
Stage 2 - Final Analysis Population Progression	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ewing Sarcoma n=45 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.	Osteosarcoma n=45 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=45 Participants	7 Participants n=45 Participants	13 Participants n=90 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=45 Participants	31 Participants n=45 Participants	69 Participants n=90 Participants
Age, Categorical >=65 years	1 Participants n=45 Participants	7 Participants n=45 Participants	8 Participants n=90 Participants
Age, Continuous	33 years n=45 Participants	34 years n=45 Participants	34 years n=90 Participants
Sex: Female, Male Female	14 Participants n=45 Participants	18 Participants n=45 Participants	32 Participants n=90 Participants
Sex: Female, Male Male	31 Participants n=45 Participants	27 Participants n=45 Participants	58 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	45 participants n=45 Participants	45 participants n=45 Participants	90 participants n=90 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Outcome measures

Measure	Osteosarcoma n=42 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Non-progression at 6 Months - Osteosarcoma	33.3 percentage Interval 19.6 to 49.6	—

PRIMARY outcome

Timeframe: Within 6 months of treatment onset

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

Objective response defined as complete response (CR) or partial response (PR) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, CR is defined as disappearance of all target and non-target lesions and normalization of tumour marker level of non-target lesions. All lymph nodes must be non-pathological in size (<10 mm short axis).

As per revised RECIST v1.1, PR is defined as a at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and non-PD/not all evaluated non-target lesions, or, CR of target lesions and non-CR/non-PD/not evaluated non-target lesions.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Outcome measures

Measure	Osteosarcoma n=42 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Objective Response Within 6 Months of Treatment Onset - Osteosarcoma	11.9 percentage Interval 4.0 to 25.6	—

PRIMARY outcome

Timeframe: Within 6 months of treatment onset

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

Objective response defined as complete response (CR) or partial response (PR) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, CR is defined as disappearance of all target and non-target lesions and normalization of tumour marker level of non-target lesions. All lymph nodes must be non-pathological in size (<10 mm short axis).

As per revised RECIST v1.1, PR is defined as a at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and non-PD/not all evaluated non-target lesions, or, CR of target lesions and non-CR/non-PD/not evaluated non-target lesions.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Outcome measures

Measure	Osteosarcoma n=39 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Objective Response Within 6 Months of Treatment Onset - Ewing Sarcoma	25.6 percentage Interval 13.0 to 42.1	—

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression/recurrence. assessed up to 2 years.

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

Best objective response rate, defined as the rate of CR or PR confirmed ≥ 4 weeks after initial documentation, as determined by investigator review of tumor assessments using RECIST v1.1. Complete or partial responses may be claimed only if the criteria for each are met at a subsequent time point as specified in the protocol (generally 4 weeks later). The BOR is the best response recorded from the start of the study treatment until the end of treatment

• Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm
• Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
• Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm
• Stable Disease (SD): Neither sufficient shrinkage to qualify for PR

Outcome measures

Measure	Osteosarcoma n=39 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma n=42 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Best Overall Response Partial response	5 Participants	3 Participants
Best Overall Response Stable disease	19 Participants	21 Participants
Best Overall Response Progressive disease	12 Participants	15 Participants
Best Overall Response Not evaluable	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

PFS is defined as the duration of time from start of treatment to time of progression (clinical and/or radiological) or death, whichever occurs first. Radiological progression is assessed by local review of tumor assessments using RECIST v1.1 criteria : at least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Osteosarcoma n=39 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma n=42 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Progression Free Survival (PFS)	4.4 months Interval 3.7 to 5.6	5.9 months Interval 4.7 to 7.4

SECONDARY outcome

Timeframe: Time from start of treatment to the time of death, assessed up to 2 years

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

OS is defined as the duration of time from start of treatment to the time of death.

Outcome measures

Measure	Osteosarcoma n=39 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma n=42 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Overall Survival (OS)	12.5 months Interval 8.5 to 20.7	10.4 months Interval 7.4 to 12.5

SECONDARY outcome

Timeframe: At 6 months

Population: All patients eligible and who received at least one complete or two incomplete treatment cycles.

Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Outcome measures

Measure	Osteosarcoma n=39 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Non-progression at 6 Months - Ewing Sarcoma	25.6 percentage Interval 13.0 to 42.1	—

SECONDARY outcome

Timeframe: Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first.

Population: Adverse event are reported for all treated patients who received at least one administration of treatment.

Number of patients who had at least one adverse event related to the treatment. Adverse events were assessed using CTCAE (5.0).

Outcome measures

Measure	Osteosarcoma n=45 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.	Osteosarcoma n=45 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish : * a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power). * a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power). Stage 1(21 evaluable patients): if \<=1 objective response within 6 months of treatment onset or \<=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited. Stage 2 (41 evaluable patients): if \>= 5 objective response within 6 months of treatment onset or \>=16 6-month non-progression, Cabozantinib was considered promising.
Incidence of Adverse Events	45 Participants	45 Participants

Adverse Events

Osteosarcoma

Serious events: 30 serious events

Other events: 45 other events

Deaths: 42 deaths

Ewing Sarcoma

Serious events: 31 serious events

Other events: 45 other events

Deaths: 37 deaths

Serious adverse events

Measure	Osteosarcoma n=45 participants at risk Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ewing Sarcoma n=45 participants at risk Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Cardiac disorders Pericardial effusion	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Cardiac disorders Hypocinetic cardiopathy	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Constipation	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Rectal hemorrhage	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Peritoneal effusion	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Death NOS	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Fatigue	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Fever	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Worsening of general status	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Thoracic pain	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Disease progression	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Hepatobiliary disorders Icteric cholestasis	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Anorectal infection	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Bronchial infection	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Kidney infection	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Sepsis	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Soft tissue infection	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Localized infection	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Injury, poisoning and procedural complications Wound complication	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations GGT increased	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Lipase increased	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Lymphocyte count decreased	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Neutrophil count decreased	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Platelet count decreased	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Pancytopenia	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Hypomagnesemia	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Diabetes	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast microcalcification presence	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Peripheral motor neuropathy	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Medullary compression	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Deficit of lower limbs	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Spinal cord compression	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Psychiatric disorders Relapse of psychiatric disorders	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Renal and urinary disorders Acute kidney injury	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 5/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	20.0% 9/45 • Number of events 11 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	22.2% 10/45 • Number of events 14 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Pneumopathy	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Pneumomediatinum	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Skin ulceration	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Vascular disorders Thromboembolic event	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.

Other adverse events

Measure	Osteosarcoma n=45 participants at risk Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ewing Sarcoma n=45 participants at risk Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and \<16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	11.1% 5/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	13.3% 6/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Cardiac disorders Sinus tachycardia	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Endocrine disorders Hypothyroidism	51.1% 23/45 • Number of events 25 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	46.7% 21/45 • Number of events 23 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Eye disorders Blurred vision	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Abdominal pain	17.8% 8/45 • Number of events 10 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	26.7% 12/45 • Number of events 12 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Constipation	31.1% 14/45 • Number of events 21 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	31.1% 14/45 • Number of events 17 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Diarrhea	68.9% 31/45 • Number of events 47 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	73.3% 33/45 • Number of events 51 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Dry mouth	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	15.6% 7/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Dysphagia	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Gastroesophageal reflux disease	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	15.6% 7/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : gastroenteritis	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Gastrointestinal pain	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Hemorrhoids	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Mucositis oral	57.8% 26/45 • Number of events 32 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	53.3% 24/45 • Number of events 31 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Nausea	42.2% 19/45 • Number of events 22 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	33.3% 15/45 • Number of events 19 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Periodontal disease	6.7% 3/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Toothache	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Gastrointestinal disorders Vomiting	15.6% 7/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	22.2% 10/45 • Number of events 12 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Fatigue	73.3% 33/45 • Number of events 41 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	71.1% 32/45 • Number of events 36 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Fever	17.8% 8/45 • Number of events 11 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	13.3% 6/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Non-cardiac chest pain	15.6% 7/45 • Number of events 11 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
General disorders Pain	13.3% 6/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Bronchial infection	8.9% 4/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Pharyngitis	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Rhinitis infective	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Skin infection	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Infections and infestations Urinary tract infection	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Injury, poisoning and procedural complications Fall	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Alanine aminotransferase increased	46.7% 21/45 • Number of events 25 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	48.9% 22/45 • Number of events 27 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Alkaline phosphatase increased	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	15.6% 7/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Aspartate aminotransferase increased	48.9% 22/45 • Number of events 28 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	48.9% 22/45 • Number of events 27 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Blood bilirubin increased	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Blood lactate dehydrogenase increased	15.6% 7/45 • Number of events 10 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	15.6% 7/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations CPK increased	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Electrocardiogram QT corrected interval prolonged	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations GGT increased	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Lipase increased	13.3% 6/45 • Number of events 18 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Lymphocyte count decreased	4.4% 2/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Neutrophil count decreased	15.6% 7/45 • Number of events 10 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	20.0% 9/45 • Number of events 11 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Platelet count decreased	31.1% 14/45 • Number of events 16 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	35.6% 16/45 • Number of events 19 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Serum amylase increased	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Thyroid stimulating hormone increased	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations Weight loss	31.1% 14/45 • Number of events 15 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	31.1% 14/45 • Number of events 14 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Investigations White blood cell decreased	6.7% 3/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Anorexia	51.1% 23/45 • Number of events 27 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	24.4% 11/45 • Number of events 13 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Hypoalbuminemia	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Hypocalcemia	13.3% 6/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Hypokalemia	17.8% 8/45 • Number of events 14 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Hypomagnesemia	24.4% 11/45 • Number of events 18 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	15.6% 7/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Metabolism and nutrition disorders Hypophosphatemia	22.2% 10/45 • Number of events 12 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	31.1% 14/45 • Number of events 23 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Back pain	17.8% 8/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	24.4% 11/45 • Number of events 14 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Bone pain	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Muscle cramp	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 6/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	15.6% 7/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	13.3% 6/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	13.3% 6/45 • Number of events 7 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Dysesthesia	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Dysgeusia	20.0% 9/45 • Number of events 10 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	33.3% 15/45 • Number of events 15 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Nervous system disorders Headache	15.6% 7/45 • Number of events 10 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	22.2% 10/45 • Number of events 12 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Psychiatric disorders Anxiety	11.1% 5/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Psychiatric disorders Depression	11.1% 5/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Psychiatric disorders Insomnia	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Renal and urinary disorders Proteinuria	15.6% 7/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Cough	24.4% 11/45 • Number of events 14 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	22.2% 10/45 • Number of events 13 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 10/45 • Number of events 10 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	17.8% 8/45 • Number of events 8 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	8.9% 4/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Respiratory, thoracic and mediastinal disorders Voice alteration	22.2% 10/45 • Number of events 11 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Alopecia	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Dry skin	28.9% 13/45 • Number of events 15 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	35.6% 16/45 • Number of events 17 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Erythema multiforme	6.7% 3/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Hair color changes	40.0% 18/45 • Number of events 18 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	35.6% 16/45 • Number of events 16 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	26.7% 12/45 • Number of events 13 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	37.8% 17/45 • Number of events 21 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Erythema	8.9% 4/45 • Number of events 4 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	2.2% 1/45 • Number of events 1 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Ungual hemorrhage	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Skin hypopigmentation	13.3% 6/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	11.1% 5/45 • Number of events 5 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Skin and subcutaneous tissue disorders Skin ulceration	8.9% 4/45 • Number of events 6 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	4.4% 2/45 • Number of events 2 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Vascular disorders Hypertension	15.6% 7/45 • Number of events 9 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Vascular disorders Thromboembolic event	6.7% 3/45 • Number of events 3 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.	0.00% 0/45 • Safety profile was continuously followed during treatment and up to 30 days after the last Cabozantinib dose or until the start of a new antitumor therapy, whichever occurs first. Adverse event are reported for all treated patients who received at least one administration of treatment. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.

Additional Information

Pr Italiano Antoine, Department of Medical Oncology

Institut Bergonie

Phone: 0524071947

Email: a.italiano@bordeaux.unicancer.fr

Results disclosure agreements

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

Restriction type: LTE60