Trial Outcomes & Findings for Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors (NCT NCT03945773)
NCT ID: NCT03945773
Last Updated: 2026-07-31
Results Overview
ORR was defined as the percentage of participants who achieved a partial response (PR) or complete response (CR) at any timepoint as determined by independent central review per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The confidence interval of the ORR was calculated using Clopper-Pearson exact method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Results posted on
2026-07-31
Participant Flow
This Phase II, open-label study was conducted in participants with unresectable, locally advanced or metastatic renal cell carcinoma with a clear-cell component who progressed after 1st line treatment with checkpoint inhibitors (CPI) at 40 sites in 7 countries (Austria, France, Germany, Netherlands, Spain, Switzerland, and the United Kingdom) between 08 January 2020 and 12 February 2026. A total of 127 participants were enrolled in the study.
Study consisted of screening period (within 15 days prior to first cabozantinib dose), treatment period (till end of study {EOS} \[18 months after last participant included in study started cabozantinib treatment\]), and post-treatment follow-up period (till participant expired/EOS, whichever was first). Participants who benefited from cabozantinib treatment at EOS continued to receive treatment until disease progression, unacceptable toxicity/withdrawal for any reason (treatment extension).
Participant milestones
| Measure |
Cohort A
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 milligrams (mg) orally once daily (q.d.) until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with vascular endothelial growth factor (VEGF)-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
42
|
|
Overall Study
Participants Who Entered Treatment Extension
|
4
|
3
|
|
Overall Study
COMPLETED
|
35
|
19
|
|
Overall Study
NOT COMPLETED
|
50
|
23
|
Reasons for withdrawal
| Measure |
Cohort A
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 milligrams (mg) orally once daily (q.d.) until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with vascular endothelial growth factor (VEGF)-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Consent Withdrawn
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
46
|
22
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors
Baseline characteristics by cohort
| Measure |
Cohort A
n=85 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.0 • n=9 Participants
|
66.2 years
STANDARD_DEVIATION 9.7 • n=27 Participants
|
64.2 years
STANDARD_DEVIATION 9.3 • n=267 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=9 Participants
|
33 Participants
n=27 Participants
|
96 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
85 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Missing
|
35 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: The Efficacy population - Independent Radiology Committee (IRC) included all participants who received at least 1 dose of study medication and provided a baseline assessment for the tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on IRC assessment.
ORR was defined as the percentage of participants who achieved a partial response (PR) or complete response (CR) at any timepoint as determined by independent central review per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The confidence interval of the ORR was calculated using Clopper-Pearson exact method.
Outcome measures
| Measure |
Cohort A
n=79 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Cohort A: Objective Response Rate (ORR) Assessed by Independent Central Review
|
40.5 percentage of participants
Interval 29.6 to 52.1
|
—
|
SECONDARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: Efficacy population-IRC=participants who received at least 1 dose of study medication; provided baseline assessment for tumour per RECIST 1.1, i.e. reported at least 1 target lesion at baseline per IRC assessment. Efficacy population-Investigator=participants who received at least 1 dose of study medication; provided baseline assessment for tumour per RECIST 1.1, i.e. reported at least 1 target lesion at baseline per Investigator assessment. Only participants with response are analyzed.
TTR was defined as the time from start of study treatment to the date of first evidence of response (PR or CR as determined by independent central review and Investigator per RECIST 1.1). The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
| Measure |
Cohort A
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=14 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Time to Response (TTR) Assessed by Independent Central Review and Investigator
Independent Central Review Assessment
|
2.8 months
Interval 2.4 to 13.8
|
2.8 months
Interval 2.7 to 8.3
|
|
Time to Response (TTR) Assessed by Independent Central Review and Investigator
Investigator Assessment
|
2.8 months
Interval 1.8 to 19.1
|
2.8 months
Interval 2.5 to 22.1
|
SECONDARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: Efficacy population-IRC=participants who received at least 1 dose of study medication; provided baseline assessment for tumour per RECIST 1.1, i.e. reported at least 1 target lesion at baseline per IRC assessment. Efficacy population-Investigator=participants who received at least 1 dose of study medication; provided baseline assessment for tumour per RECIST 1.1, i.e. reported at least 1 target lesion at baseline per Investigator assessment. Only participants with response are analyzed.
DOR was defined as the time from first documented response (PR or CR as determined by independent central review and Investigator per RECIST 1.1) to either disease progression (as determined by independent central review and Investigator per RECIST 1.1) or death due to any cause, whichever occurs first. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of ≥ 5 millimeters (mm). DOR was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=14 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Duration of Response (DOR) Assessed by Independent Central Review and Investigator
Independent Central Review Assessment
|
NA months
Interval 11.6 to
NA indicates that the median and upper limit of 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.
|
8.3 months
Interval 5.6 to
NA indicates that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
|
Duration of Response (DOR) Assessed by Independent Central Review and Investigator
Investigator Assessment
|
11.2 months
Interval 8.3 to 16.7
|
8.3 months
Interval 3.7 to 11.1
|
SECONDARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: Efficacy population-IRC=all participants who received at least 1 dose of study medication and provided baseline assessment for tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on IRC assessment. Efficacy population-Investigator=all participants who received at least 1 dose of study medication and provided baseline assessment for tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on Investigator assessment.
DCR was defined as the percentage of participants who achieved a PR, CR or stable disease (SD) as determined by independent central review and Investigator per RECIST 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. The PD was defined at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of ≥ 5 mm.
Outcome measures
| Measure |
Cohort A
n=85 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Disease Control Rate (DCR) Assessed by Independent Central Review and Investigator
Investigator Assessment
|
83.5 percentage of participants
Interval 73.9 to 90.7
|
81.0 percentage of participants
Interval 65.9 to 91.4
|
|
Disease Control Rate (DCR) Assessed by Independent Central Review and Investigator
Independent Central Review Assessment
|
84.8 percentage of participants
Interval 75.0 to 91.9
|
82.5 percentage of participants
Interval 67.2 to 92.7
|
SECONDARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: Efficacy population-IRC=all participants who received at least 1 dose of study medication and provided baseline assessment for tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on IRC assessment. Efficacy population-Investigator=all participants who received at least 1 dose of study medication and provided baseline assessment for tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on Investigator assessment.
PFS was defined as the time from start of study treatment to either disease progression (as determined by independent central review and Investigator per RECIST 1.1) or death due to any cause, whichever occurs first. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of ≥ 5 mm. PFS was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A
n=85 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Progression-free Survival (PFS) Assessed by Independent Central Review and Investigator
Independent Central Review Assessment
|
10.9 months
Interval 8.2 to 14.2
|
8.3 months
Interval 5.6 to 11.1
|
|
Progression-free Survival (PFS) Assessed by Independent Central Review and Investigator
Investigator Assessment
|
10.9 months
Interval 8.2 to 13.6
|
8.2 months
Interval 5.6 to 9.2
|
SECONDARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: The Efficacy population - IRC included all participants who received at least 1 dose of study medication and provided a baseline assessment for the tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on IRC assessment.
ORR was defined as the percentage of participants who achieved a PR or CR at any timepoint as determined by independent central review per RECIST 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The CI of the ORR was calculated using Clopper-Pearson exact method.
Outcome measures
| Measure |
Cohort A
n=40 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Cohort B: Objective Response Rate Assessed by Independent Central Review
|
27.5 percentage of participants
Interval 14.6 to 43.9
|
—
|
SECONDARY outcome
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 monthsPopulation: The Efficacy population - Investigator included all participants who received at least 1 dose of study medication and provided a baseline assessment for the tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on Investigator assessment.
ORR was defined as the percentage of participants who achieved a PR or CR at any timepoint as determined by Investigator per RECIST 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The CI of the ORR was calculated using Clopper-Pearson exact method.
Outcome measures
| Measure |
Cohort A
n=85 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Objective Response Rate Assessed by Investigator
|
49.4 percentage of participants
Interval 38.4 to 60.5
|
33.3 percentage of participants
Interval 19.6 to 49.5
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to end of study, 45 monthsPopulation: The Efficacy population - Investigator included all participants who received at least 1 dose of study medication and provided a baseline assessment for the tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on Investigator assessment.
OS was defined as the time from the start of treatment until death due to any cause. OS was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A
n=85 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS) Assessed by Investigator
|
24.3 months
Interval 18.5 to 31.8
|
24.1 months
Interval 17.1 to
NA indicates that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 40Population: The Efficacy population - Investigator included all participants who received at least 1 dose of study medication and provided a baseline assessment for the tumour according to RECIST 1.1, i.e. reported at least 1 target lesion at baseline based on Investigator assessment. Only participants with data collected at Baseline and Month 40 are reported.
The FKSI-DRS questionnaire consisted of 9-items to evaluate participant's symptoms in the past 7 days such as lack of energy, pain, weight-loss, bone-pain, shortness of breath, fatigue, fever, blood in urine etc. Participants rated each question from 0 (not at all) to 4 (very much). Total score was calculated as the sum of the item responses divided by the number of items completed and multiplied by the total number of items in the scale. Total score ranged from 0 to 36. Higher scores indicated less symptoms. Baseline was defined as the last questionnaire answered prior to the first dose of study drug. A negative change from baseline indicated worse outcome.
Outcome measures
| Measure |
Cohort A
n=37 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=22 Participants
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI-DRS) Score at Month 40
|
-3.0 score on a scale
Standard Deviation 5.4
|
-2.4 score on a scale
Standard Deviation 5.6
|
Adverse Events
Cohort A
Serious events: 51 serious events
Other events: 85 other events
Deaths: 46 deaths
Cohort B
Serious events: 16 serious events
Other events: 41 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Cohort A
n=85 participants at risk
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 participants at risk
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
2/85 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Anal fistula
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Femoral hernia
|
1.2%
1/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Jejunal perforation
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Pyrexia
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Fatigue
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
General physical health deterioration
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Malaise
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Hepatobiliary disorders
Cholestasis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
COVID-19
|
9.4%
8/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
11.9%
5/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Pneumonia
|
3.5%
3/85 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Sepsis
|
3.5%
3/85 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Enterocolitis infectious
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Escherichia infection
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Peritonitis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Tooth infection
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Wound infection
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
SARS-CoV-2 test positive
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
2/85 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Ataxia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Headache
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Radicular pain
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
3/85 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Vascular disorders
Hypotension
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Vascular disorders
Aortic aneurysm
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/85 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
Other adverse events
| Measure |
Cohort A
n=85 participants at risk
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with ipilimumab and nivolumab received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
Cohort B
n=42 participants at risk
Participants who had radiographically progressed after 1 prior treatment with CPI therapy combined with VEGF-targeted therapy received cabozantinib 60 mg orally q.d. until end of the study, disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.3%
13/85 • Number of events 14 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.6%
9/85 • Number of events 10 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Dry mouth
|
8.2%
7/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
8/85 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.2%
7/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
3.5%
3/85 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Toothache
|
7.1%
6/85 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Fatigue
|
37.6%
32/85 • Number of events 45 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
45.2%
19/42 • Number of events 22 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Asthenia
|
27.1%
23/85 • Number of events 34 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
14.3%
6/42 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Oedema peripheral
|
8.2%
7/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Mucosal inflammation
|
8.2%
7/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Pyrexia
|
8.2%
7/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
General disorders
Chest pain
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
10.6%
9/85 • Number of events 11 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
9/85 • Number of events 12 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
5/85 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Infections and infestations
Oral candidiasis
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
0.00%
0/42 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Alanine aminotransferase increased
|
22.4%
19/85 • Number of events 22 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
31.0%
13/42 • Number of events 16 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
21.2%
18/85 • Number of events 24 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
33.3%
14/42 • Number of events 15 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Weight decreased
|
18.8%
16/85 • Number of events 16 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
14.3%
6/42 • Number of events 7 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Ageusia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
19.0%
8/42 • Number of events 12 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.4%
8/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Blood creatinine increased
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.2%
7/85 • Number of events 7 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Blood bilirubin increased
|
5.9%
5/85 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Platelet count decreased
|
4.7%
4/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
48.2%
41/85 • Number of events 51 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
57.1%
24/42 • Number of events 26 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Lethargy
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
5/85 • Number of events 7 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
26.2%
11/42 • Number of events 14 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.2%
7/85 • Number of events 13 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
11.9%
5/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
9/85 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.2%
7/85 • Number of events 12 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.5%
3/85 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.7%
4/85 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.9%
5/85 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
17/85 • Number of events 21 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
11.9%
5/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Headache
|
11.8%
10/85 • Number of events 11 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
14.3%
6/42 • Number of events 7 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Stomatitis
|
38.8%
33/85 • Number of events 45 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
47.6%
20/42 • Number of events 26 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Nausea
|
31.8%
27/85 • Number of events 33 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
31.0%
13/42 • Number of events 15 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Constipation
|
27.1%
23/85 • Number of events 30 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
23.8%
10/42 • Number of events 11 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
15/85 • Number of events 18 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
23.8%
10/42 • Number of events 14 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Dizziness
|
14.1%
12/85 • Number of events 13 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.6%
9/85 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
16.7%
7/42 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Endocrine disorders
Hypothyroidism
|
29.4%
25/85 • Number of events 26 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
33.3%
14/42 • Number of events 14 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
70.6%
60/85 • Number of events 100 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
73.8%
31/42 • Number of events 55 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.1%
12/85 • Number of events 14 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
16.7%
7/42 • Number of events 10 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
6/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
19.0%
8/42 • Number of events 10 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.6%
9/85 • Number of events 12 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
14.3%
6/42 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
8/85 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
5/85 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Nervous system disorders
Dysgeusia
|
23.5%
20/85 • Number of events 25 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
11.9%
5/42 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Renal and urinary disorders
Proteinuria
|
16.5%
14/85 • Number of events 17 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
14.3%
6/42 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Renal and urinary disorders
Haematuria
|
3.5%
3/85 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 6 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
21.2%
18/85 • Number of events 19 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
19.0%
8/42 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.6%
15/85 • Number of events 19 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
19.0%
8/42 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
10/85 • Number of events 14 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
19.0%
8/42 • Number of events 9 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.9%
5/85 • Number of events 5 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
2.4%
1/42 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
1/85 • Number of events 1 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
45.9%
39/85 • Number of events 50 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
23.8%
10/42 • Number of events 20 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.8%
10/85 • Number of events 10 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
23.8%
10/42 • Number of events 10 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.9%
11/85 • Number of events 13 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
19.0%
8/42 • Number of events 10 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
11/85 • Number of events 19 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
9.5%
4/42 • Number of events 7 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
9.4%
8/85 • Number of events 8 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
4.8%
2/42 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 3 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.4%
2/85 • Number of events 2 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
7.1%
3/42 • Number of events 4 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
|
Vascular disorders
Hypertension
|
50.6%
43/85 • Number of events 56 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
47.6%
20/42 • Number of events 22 • Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow up per participant, approximately 73 months.
The safety population included all participants who received at least 1 dose of study treatment. As pre-specified in the statistical analysis plan, results are presented by cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place