NCT04200443 · ADVERSE EVENTS

Adverse events

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma · Source last updated 2026-05-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events were assessed from the time of initial treatment up to the end of last treatment, up to 5 years. All-Cause Mortality was assessed from start of treatment to time of death, up to 5 years.
Other-event reporting threshold: 0%

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.	9 / 42	42 / 42	25 / 42
Cohort 2 - Patients With Other Soft Tissue Sarcomas Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included. Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.	11 / 30	29 / 30	26 / 30

Group identifiers: EG000: Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma · EG001: Cohort 2 - Patients With Other Soft Tissue Sarcomas

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Small intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Death NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
2
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
7
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Hyponatremia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
ANC decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
13
num At Risk
42
num Events
25
group Id
EG001
num Affected
8
num At Risk
30
num Events
12
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
8
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Blood and lymphatic system disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
2
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Eosinophilia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Hypoproteinemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
2
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Hyperparathyroidism

Complete source fields

description

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

event Groups

deaths Num Affected
25
deaths Num At Risk
42
description
Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
id
EG000
other Num Affected
42
other Num At Risk
42
serious Num Affected
9
serious Num At Risk
42
title
Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma
deaths Num Affected
26
deaths Num At Risk
30
description
Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included. Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
id
EG001
other Num Affected
29
other Num At Risk
30
serious Num Affected
11
serious Num At Risk
30
title
Cohort 2 - Patients With Other Soft Tissue Sarcomas

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
ANC decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
13
num At Risk
42
num Events
25
group Id
EG001
num Affected
8
num At Risk
30
num Events
12
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
8
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Blood and lymphatic system disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
2
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Eosinophilia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Hypoproteinemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
2
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Hyperparathyroidism

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Small intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Death NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
2
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
7
group Id
EG001
num Affected
0
num At Risk
30
num Events
0
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
30
num Events
1
term
Hyponatremia

time Frame

Adverse events were assessed from the time of initial treatment up to the end of last treatment, up to 5 years. All-Cause Mortality was assessed from start of treatment to time of death, up to 5 years.

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