Trial Outcomes & Findings for Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma (NCT NCT04804813)
NCT ID: NCT04804813
Last Updated: 2025-04-11
Results Overview
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event.
Recruitment status
COMPLETED
Target enrollment
388 participants
Primary outcome timeframe
Up to 26 weeks
Results posted on
2025-04-11
Participant Flow
Participants took part in the survey at 102 investigative sites in Japan, from 29 March 2021 to 25 July 2024.
Participants with renal cell carcinoma who received Cabozantinib were enrolled. Participants received Cabozantinib as part of a routine medical care.
Participant milestones
| Measure |
Cabozantinib Monotherapy
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Overall Study
STARTED
|
325
|
63
|
|
Overall Study
COMPLETED
|
322
|
63
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Cabozantinib Monotherapy
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.7 Years
STANDARD_DEVIATION 11.34 • n=322 Participants
|
68.7 Years
STANDARD_DEVIATION 11.55 • n=63 Participants
|
68.7 Years
STANDARD_DEVIATION 11.36 • n=385 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=322 Participants
|
17 Participants
n=63 Participants
|
115 Participants
n=385 Participants
|
|
Sex: Female, Male
Male
|
224 Participants
n=322 Participants
|
46 Participants
n=63 Participants
|
270 Participants
n=385 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
Adverse Events
|
216 Participants
|
46 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
Serious Adverse Events
|
73 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
103 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=425 Count of Adverse Events
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=92 Count of Adverse Events
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Percentage of Adverse Events Leading to Dose Changes of Cabozantinib
|
72.0 Percent of Adverse Events
|
64.1 Percent of Adverse Events
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Adverse Drug Reactions
|
193 Participants
|
41 Participants
|
|
Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Serious Adverse Drug Reactions
|
49 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Drug Reactions
|
80 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=373 Count of Adverse Drug Reactions
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=70 Count of Adverse Drug Reactions
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib
|
72.1 Percent of Adverse Drug Reactions
|
74.3 Percent of Adverse Drug Reactions
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
Adverse Drug Reaction of Hepatic Failure and Hepatic Dysfunction
|
52 Participants
|
16 Participants
|
|
Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=61 Count of Adverse Drug Reactions
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=19 Count of Adverse Drug Reactions
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib
|
77.0 Percent of Adverse Drug Reactions
|
78.9 Percent of Adverse Drug Reactions
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis
Adverse Drug Reaction of Pancreatitis
|
9 Participants
|
3 Participants
|
|
Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis
Serious Adverse Drug Reactions of Pancreatitis
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=10 Count of Adverse Drug Reactions
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=4 Count of Adverse Drug Reactions
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib
|
50.0 Percent of Adverse Drug Reactions
|
100.0 Percent of Adverse Drug Reactions
|
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Best response was assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response was defined as the level of best response in assessment with complete response (CR), partial response (PR) during the observational period.
Outcome measures
| Measure |
Cabozantinib Monotherapy
n=322 Participants
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 Participants
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Percentage of Participants Who Achieve or Maintain Any Best Response
|
106 Participants
|
26 Participants
|
Adverse Events
Cabozantinib Monotherapy
Serious events: 73 serious events
Other events: 165 other events
Deaths: 15 deaths
Cabozantinib + Nivolumab Combination Therapy
Serious events: 28 serious events
Other events: 24 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cabozantinib Monotherapy
n=322 participants at risk
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 participants at risk
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Infections and infestations
Peritonitis
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pharyngitis
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Sepsis
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Subperiosteal abscess
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Vascular device infection
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
3.2%
2/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to heart
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
2.5%
8/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
3.2%
2/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer fatigue
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
3.2%
2/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Hypothyroidism
|
2.5%
8/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
4.8%
3/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
5/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Seizure
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Cataract
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.93%
3/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Aortic dissection
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Hypertension
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.93%
3/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
6.3%
4/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
3.2%
2/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
3.2%
2/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
6.3%
4/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal disorder
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.93%
3/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Death
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Malaise
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
General physical health deterioration
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Mucosal disorder
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Amylase increased
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Lipase increased
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Platelet count decreased
|
0.62%
2/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Liver function test abnormal
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Protein urine present
|
0.31%
1/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
1.6%
1/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Other adverse events
| Measure |
Cabozantinib Monotherapy
n=322 participants at risk
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care.
|
Cabozantinib + Nivolumab Combination Therapy
n=63 participants at risk
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care.
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
17/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
3.2%
2/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Hypertension
|
8.7%
28/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
6.3%
4/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.9%
35/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
6.3%
4/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
17/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
0.00%
0/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
8.7%
28/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
9.5%
6/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.4%
40/322 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
12.7%
8/63 • Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place